Compounding: Inspections, Recalls, and other Actions

Find 2014 - 2015 Compounding: Inspections, Recalls, and other Actions in the FDA Archive

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Abbott's Compounding Pharmacy Inc., Berkeley, CA - 503A Facility

Warning Letter (04/04/2017)
483 Issued 01/08/2016 (PDF - 2MB)

ABC Pharmacy, Inc., Encino, CA - 503A Facility

FMD-145 Letter Issued 07/06/2020 (PDF - 63KB)
Referral Letter to the California State Board of Pharmacy Issued 07/06/2020 (PDF - 80KB)
483 Issued 12/20/2019 (PDF - 254KB)

Abilene Nuclear LLC, (dba National Central Pharmacy), Abilene, TX - 503A Facility - Ceased Compounding Operations

FMD-145 Letter Issued 01/25/2022
Untitled Letter Issued 10/22/2020 (PDF - 818KB)
483 Issued 11/07/2019 (PDF - 928KB)

Abrams Royal Pharmacy, Dallas, TX - 503A Facility

FMD-145 Letter Issued 09/28/2016
Warning Letter (07/14/2014)
FDA Press Release: FDA Announces Voluntary Nationwide Recall of All Non-expired Sterile Drugs from Abrams Royal Compounding Pharmacy (12/21/2013)
483 Issued 12/20/2013 (PDF – 5.3MB)
Firm Press Release: Abrams Royal Pharmacy Issues Voluntary Nationwide Recall of All Lots of Unexpired Sterile Products Due to Lack of Sterility Assurance (12/18/2013)

Abrams Royal Pharmacy II, LLC, Plano, TX - 503A Facility

FMD-145 Letter Issued 05/03/2016 (PDF - 275KB)
483 Issued 5/11/2015 (PDF - 466KB)

Absolute Pharmacy, LLC, Lutz, FL - 503A Facility - De-registered as an Outsourcing Facility

Referral Letter to the Florida State Board of Pharmacy Issued 02/15/2017 (PDF - 307KB)
483 Issued 04/11/2016 (PDF - 1.7MB)
Warning Letter (04/27/2015)
483 Issued 11/19/2014

Absolute Veterinary Compounding Pharmacy, Weatherford, TX - 503A Facility

FMD-145 Letter Issued 02/01/2021 (PDF - 177KB)
483 Issued 06/14/2017 (PDF - 125KB)

AcariaHealth Pharmacy, Inc., Falls Chuch, VA - 503A Facility - Ceased Compounding Operations

Referral Letter to the Virginia State Board of Pharmacy dated 01/29/2020 (PDF - 113KB)
FMD-145 Letter Issued 01/29/2020 (PDF - 121KB)
483 Issued 09/12/2018 (PDF - 534KB)

Accurate Rx Pharmacy Consulting, LLC (dba Accurate Rx Pharmacy), Columbia, MO - 503A Facility

FMD-145 Letter Issued 06/16/2022
Referral Letter to the Missouri Board of Pharmacy dated 06/16/2022 (PDF - 259KB)
483 Issued 07/15/2021 (PDF - 1.01MB)
Warning Letter (09/02/2020)
483 Issued 09/19/2018 (PDF - 630KB)
483 Issued 08/15/2017 (PDF - 228KB)

A Chem Rx, LLC, (dba Cortez Drugs), Brooksville, FL - 503A Facility

FMD-145 Letter Issued 06/16/2020 (PDF - 184KB)
483 Issued 02/07/2020 (PDF - 266KB)

ACRX Specialty Pharmacy Inc., Las Vegas, NV - 503A Facility

Referral Letter to the Nevada State Board of Pharmacy dated 07/13/2022 (PDF - 364KB)
FMD-145 Letter Issued 07/13/2022
483 Issued 07/23/2021 (PDF - 1.33MB)
Warning Letter (07/24/2020)
483 Issued 03/20/2019 (PDF - 1.64MB)

Advanced Care Infusion-Shelby, (see Tri-Med, Inc.), Shelby Township, MI - 503A Facility

Advanced Compounding Solutions, (see New England Life Care, Inc.), Woburn, MA - 503A Facility

Advanced Infusion Solutions, Clinton, MS - 503A Facility

483 Response Dated 11/16/2015 (PDF - 1.3MB)
483 Issued 10/27/2015 (PDF - 621KB)

Advanced Infusion Solutions, (see Bond Pharmacy, Inc.), Ridgeland, MS - 503A Facility

Advanced Nutriceuticals, LLC, Indianapolis, IN - 503A Facility

Warning Letter (11/10/2021)
483 Issued 10/29/2020 (PDF - 3.61MB)

Advanced Physician Solutions, Inc., N Hollywood, CA - 503A Facility - Out of business

Warning Letter (11/03/2015)
483 Issued 01/16/2015 (PDF - 2.4MB)

Advanced Specialty Pharmacy (dba Meds IV), Bessemer, AL - 503A Facility

DOJ Press Release: Federal Criminal Charges Filed Against Two Pharmacists for Adulteration of Drugs in Connection with Alabama-Based Compounding Pharmacy (1/28/2016)
Warning Letter (03/16/2012)

Aerosol Science Laboratories Inc., Camarillo, CA - 503A Facility

Warning Letter (10/29/2008)

Age Management, Santa Barbara, CA - 503A Facility

Warning Letter (04/18/2022)
483 Issued 04/12/2021 (PDF - 1.25MB)

Akina Pharmacy, Chantilly, VA - 503A Facility

FMD-145 Letter Issued 06/08/2017
Referral Letter to the Virginia State Board of Pharmacy Issued 06/08/2017 (PDF - 62KB)
483 Issued 08/10/2016 (PDF - 492KB)

Akorn Pharmaceuticals Inc. Decatur, IL - 503A Facility

483 Issued 06/10/2016 (PDF - 1.7MB)

Alexander Infusion, LLC (dba Avanti Health Care Services), New Hyde Park, NY - 503A Facility - De-registered as an Outsourcing Facility

Warning Letter Closeout (05/08/2017)
Referral Letter to the New York State Board of Pharmacy Issued 05/08/2017 (PDF - 646KB)
FMD-145 Letter Issued 05/08/2017 (PDF - 267KB)
483 Issued 08/01/2016 (PDF - 607KB)
Warning Letter (03/27/2015)
483 Issued 07/09/2014 (PDF - 1.4MB)

Alexandria Medical Arts Pharmacy & Compounding Laboratory, (see J & F International Inc.), Alexandria, VA - 503A Facility

Alfred I. duPont Hospital for Children, Wilmington, DE - 503A Facility

Referral Letter to the Delaware State Board of Pharmacy Issued 04/28/2017 (PDF - 910KB)
483 Issued 06/29/2016 (PDF - 686KB)

Algunas, Inc. (dba Woodland Hills Compounding Pharmacy), Woodland Hills, CA - 503A Facility

FMD-145 Letter Issued 03/25/2020
483 Issued 10/11/2018 (PDF - 1.14MB)
Amended 483 Issued 05/02/2016 (PDF - 374KB)
483 Issued 04/29/2016 (PDF - 427KB)
Warning Letter 7/17/2017

Allegheny Health Network Home Infusion, LLC, Sharpsburg, PA - 503A Facility

FMD-145 Letter Issued 04/30/2020
483 Issued 09/25/2018 (PDF - 224KB)

Alwan's Pharmacy (see American Pharmacy of Illinois, Inc.), Peoria, IL - 503A Facility

Ambient Healthcare of Central Florida Inc., Ocala, FL - 503A Facility

Referral Letter to Florida State Board of Pharmacy Issued 10/09/2015 (PDF - 321KB)
483 Issued 09/15/2014 (PDF - 637KB)

American Family Pharmacy, LLC, Indianapolis, IN - 503A Facility

Amended 483 Issued 07/21/2014 (PDF - 1.8MB)
483 Issued 07/08/2014 (PDF - 2.3MB)

American Hormones Inc. Poughkeepsie, NY - 503A Facility

FMD-145 Letter Issued 04/06/2016 (PDF - 81KB)

American Hormones, Inc., Wappingers Falls, NY - 503A Facility

Warning Letter (01/10/2008)

American Pharmacy of Illinois, Inc. (dba Alwan's Pharmacy), Peoria, IL - 503A Facility

483 Issued 07/17/2018 (PDF - 988KB)
Warning Letter (07/22/2016)
Amended 483 Issued 11/17/2015 (PDF - 1.4MB)
483 Issued 10/28/2015 (PDF - 1.4MB)

American Specialty Pharmacy, Dallas, TX - 503A Facility - Out of business

Warning Letter (04/04/2017)
483 Issued 08/05/2015 (PDF - 998KB)

American Specialty Pharmacy, Plano, TX - 503A Facility - Ceased Compounding Operations

Warning Letter (06/28/2016)
483 Issued 12/19/2014

American Specialty Pharmacy, Inc., (dba ASP Cares), San Antonio, TX - 503A Facility - De-registered as an Outsourcing Facility

Warning Letter (04/05/2021)
483 Issued 08/23/2018 (PDF - 1016KB)
FMD-145 Letter Issued 10/26/2017 (PDF - 63KB)
483 Issued 03/02/2017 (PDF - 261KB)

Americare Compounding, LLC, Garden City South, NY - 503A Facility

Referral Letter to the New York State Board of Pharmacy Issued 03/22/2017 (PDF - 223KB)
483 Issued 06/22/2015 (PDF - 903KB)
Warning Letter (04/22/2014)
483 Issued 06/19/2013 (PDF – 754KB)

Ameridose, LLC, Westborough, MA - 503A Facility

483 Issued 11/09/2012
Firm Press Release: Ameridose Issues Recall of All Products (10/31/2012)
FDA Press Release: FDA reports voluntary recall of all Ameridose drugs products (10/31/2012)

Amex Pharmacy, (see Pacifico National Inc.), Melbourne, FL - 503A Facility

Anazaohealth Corporation, Tampa, FL - 503A Facility

Referral Letter to Florida Board of Pharmacy Issued 02/21/2014 (PDF - 375KB)
483 Issued 02/22/2013 (PDF - 857KB)

Anazaohealth Corporation, Las Vegas, NV - 503B Facility

483 Issued 07/29/2022 (PDF - 853KB)
Warning Letter (08/18/2021)
483 Issued 09/19/2019 (PDF - 501KB)
Amended 483 Issued 04/06/2017 (PDF - 1.3MB)
483 Issued 03/24/2017 (PDF - 1MB)
Warning Letter (12/09/2015)
483 Issued 01/30/2015 (PDF - 2MB)

Anchor Drugs Pharmacy, (see Jajco, Inc.), South San Francisco, CA - 503A Facility

Anderson Compounding Pharmacy, Inc. dba Anderson Compounding Pharmacy, Bristol, TN - 503A Facility

FMD-145 Letter Issued 02/18/2022
Warning Letter (01/13/2020)
483 Issued 04/05/2019 (PDF - 1.09MB)

Anderson Holdings Inc. (dba Wingate's Pharmacy and Compounding), Nashua, NH - 503A Facility

Referral Letter to State of New Hampshire Board of Pharmacy Issued 06/07/2016 (PDF - 32KB)
483 Response Dated 02/29/2016 (PDF - 1.6MB)
483 Issued 02/19/2016 (PDF - 1.7MB)

Apex Pharmacy, LLC, Beckley, WV - 503A Facility

Untitled Letter Issued 07/28/2020 (PDF - 164KB)
483 Issued 11/07/2019 (PDF - 250KB)

Apollo Care LLC, Columbia, MO - 503B Facility

483 Issued 04/05/2023 (PDF - 1.84MB)
483 Issued 09/8/2021 (PDF - 2MB)
Warning Letter (03/20/2019)
483 Issued 03/13/2018 (PDF - 2.5MB)

ApothéCure, Inc., Dallas, TX - 503A Facility

483 Issued 04/17/2013 (PDF - 1.6MB)
Firm Press Release: ApothéCure, Inc. Recalls All Lots of All Sterile Products Compounded, Repackaged, and Distributed by ApothéCure, Inc. Due to Sterility Assurance Concerns (04/15/2013)
FDA Press Release: FDA issues Alert About Lack of Sterility Assurance of Drug Products from ApothéCure, Inc. and NuVision Pharmacy and of Forthcoming Recall (04/15/2013)
DOJ Press Release: Dallas Compounding Pharmacy Owner Pleads Guilty in Connection with Misbranded Drug Shipment (4/24/2012)

APS Pharmacy, (see Drug Depot, Inc.), Palm Harbor, FL - 503A Facility

ARJ Infusion Services, Inc., Lenexa, KS - 503A Facility

FMD-145 Letter Issued 03/06/2019 (PDF - 88KB)
Warning Letter CloseOut (03/06/2019)
Referral Letter to the Kansas State Board of Pharmacy Issued 03/06/2019 (PDF - 73KB)
Warning Letter (04/02/2018)
483 Issued 05/25/2017 (PDF - 296KB)

Ark Pharmacy, PC (dba Regency Medical Pharmacy), Newbury Park, CA - 503A Facility

FMD-145 Letter Issued 07/25/2022
483 Issued 2/24/2022 (PDF - 271 KB)

Arnold Professional Pharmacy, Arnold, MD - 503A Facility

FMD - 145 Issued 11/3/2022
483 Issued 03/18/2022 (PDF - 713KB)
483 Issued 09/05/2018 (PDF - 183KB)
Warning Letter (04/07/2017)
483 Issued 05/06/2016 (PDF - 385KB)

ASP Cares, (see American Specialty Pharmacy, Inc.), San Antonio, TX - 503A Facility - De-registered as an Outsourcing Facility

Aspirar Pharmacy, LLC, Cary, NC - 503A Facility

Referral Letter to the North Carolina State Board of Pharmacy Issued 08/19/2019 (PDF - 65KB)
FMD-145 Letter Issued 08/19/2019 (PDF - 63KB)

Assurance Infusion, (see Nanobots Healthcare, LLC), Houston, TX - 503A Facility

Asteria Health, (see FH Investments Inc.), Birmingham, AL - 503B Facility

Athena Pharmacy (see Paradigm Healthcare Solutions, LLC), Mount Juliet, TN - 503A Facility

Athenex Pharma Solutions, LLC, Clarence, NY - 503B Facility

483 Issued 09/16/2022 (PDF - 503KB)
483 Issued 08/28/2019 (PDF - 334KB)
FDA Statement: FDA Statement on Court Ruling Related to Compounded Bulk Drug Substances and the Agency’s Ongoing Efforts to Implement its Compounding Authorities (08/06/2019)
Firm Press Release: Athenex Provides an Update Regarding the Vasopressin Case (08/02/2019)
Untitled Letter Issued 02/13/2019 (PDF - 161KB)
483 Issued 12/13/2017 (PDF - 598KB)

Atlas Pharmaceuticals, LLC, Phoenix, AZ - 503B Facility

FMD-145 Letter Issued 05/03/2022
483 Issued 06/11/2021 (PDF - 860KB
Warning Letter (09/11/2018)
483 Issued 09/26/2017 (PDF - 2.8MB)

Auro Pharmacies, Inc., La Habra, CA - 503A Facility - Out of business

FMD-145 Letter Issued 04/11/2023
Referral Letter to the California State Board of Pharmacy Issued 04/06/2023 (PDF - 311KB)
483 Issued 08/12/2022 (PDF - 344KB)
483 Issued 10/18/2019 (PDF - 1.93MB)
Warning Letter (09/24/2018)
483 Issued 06/29/2017 (PDF - 2.9MB)
Warning Letter (12/13/2016)
Amended 483 Issued 12/02/2016 (PDF - 1.9MB)
483 Issued 12/02/2016 (PDF - 2MB)
483 Issued 11/05/2015 (PDF - 1.7MB)

Avanti Health Care Services, (see Alexander Infusion, LLC), New Hyde Park, NY - 503A Facility

Avella of Deer Valley, Inc. (dba Avella Specialty Pharmacy), Phoenix, AZ - 503A Facility - De-registered as an Outsourcing Facility

Untitled Letter Issued 03/31/2021 (PDF - 171KB)
483 (Amendment 2) Issued 04/25/2018 (PDF - 778KB)
483 Issued 04/20/2018 (PDF - 697KB)
483 (Amendment 1) Issued 04/19/2018 (PDF - 724KB)
FMD-145 Letter Issued 08/23/2017 (PDF - 53KB)
FMD-145 Letter Issued 02/15/2017 (PDF - 187KB)
Untitled Letter Issued 02/03/2017 (PDF - 1.33MB)
Amended 483 Issued 07/31/2015 (PDF - 297KB)
483 Issued 07/29/2015 (PDF - 567KB)
Warning Letter Response Dated 02/10/2014
Warning Letter (01/17/2014)
Firm Press Release: Avella Specialty Pharmacy Issues Voluntary Nationwide Recall of Two Medications Due to Concerns of Sterility Assurance at Testing Vendor (09/09/2013)
483 Issued 02/25/2013 (PDF - 1010KB)

Avella Specialty Pharmacy, (formerly Advanced Pharma, Inc.), Houston, TX - 503A Facility - Out of business

Untitled Letter Issued 08/14/2018 (PDF - 88KB)
Firm Press Release: Advanced Pharma, Inc. d/b/a Avella of Houston Issues Voluntary Nationwide Recall of Specific Lots of Potassium Phosphate and Succinylcholine Repacked and/or Compounded at its Houston Location as a Result of Hospira, Inc’s June 15, 2017 Recall of Such Products Due to a Potential Lack of Sterility Assurance (06/22/2017)
Firm Press Release: Advanced Pharma, Inc. D/B/A Avella of Houston Issues Voluntary Nationwide Recall of All Unexpired Nitroglycerin Injection In 5% Dextrose USP Products Produced At Its Houston Location From March 3, 2017 Through May 31, 2017 Due To Sub-Potency (06/15/2017)
Firm Press Release: Avella Specialty Pharmacy Issues Voluntary Nationwide Recall of all Sterile Products Produced at Advanced Pharma Houston Location from September 1, 2016 through February 16, 2017 Due to Potential Inaccuracy of Latex Free Label Reference (02/23/2017)
483 Issued 07/22/2016 (PDF - 920KB)
483 Issued 03/17/2014 (PDF - 638KB)

Avenue Pharmacy, Inc., (dba Pathway Pharmacy), Ocala, FL - 503A Facility

483 Issued 12/06/2019 (PDF - 499KB)

Axia Pharmaceuticals, (see Fusion IV Pharmaceuticals Inc.), Los Angeles, CA - 503A Facility

Axis Pharmacy Northwest, (see Shiraz Specialty Pharmacy Inc.), Mountlake Terrace, WA - 503A Facility

Axium Healthcare Pharmacy (dba Balanced Solutions Compounding), Lake Mary, FL - 503A Facility - Out of business

Warning Letter (07/16/2013)
FDA Press Release: FDA Announces Voluntary Nationwide Recall by Balanced Solutions Compounding Pharmacy (04/21/2013)
Firm Press Release: Balanced Solutions Compounding Pharmacy, LLC. Announces a Voluntary Nationwide Recall of All Sterile Compounded Products Due to a Lack of Sterility Assurance (04/17/2013)
483 Issued 03/15/2013 (PDF - 638KB)

B & B Pharmacy, (see BBS Pharmacy, Inc.), Bellflower, CA - 503A Facility

Balanced Solutions Compounding, (see Axium Healthcare Pharmacy), Lake Mary, FL - 503A Facility - Out of business

Ballard Plaza Pharmacy 1 Inc., Seattle, WA - 503A Facility - Out of business

Warning Letter (08/01/2017)
Amended 483 Issued 06/10/2016 (PDF - 1.7MB)
483 Issued 05/17/2016 (PDF - 1.6MB)

Banner Pharmacy Services, LLC, Chandler, AZ - 503A Facility - De-registered as an Outsourcing Facility

FMD-145 Letter Issued 04/09/2020 (PDF - 63KB)
Referral Letter to the Arizona State Board of Pharmacy Issued 04/09/2020 (PDF - 83KB)
483 Issued 10/08/2019 (PDF - 1.15MB)
Amended 483 Issued 09/20/2017 (PDF - 3.1MB)
483 Issued 09/20/2017 (PDF - 2.9MB)
Warning Letter (05/05/2016)
483 Issued 03/20/2015 (PDF - 1.8MB)

Baptist Health Medical Towers Pharmacy and Infusion Services, Little Rock, AR - 503A Facility

Warning Letter (09/12/2017)
483 Issued 04/28/2016 (PDF - 1.3MB)

Barclay Luke & Pillai Specialty Pharmacy PLLC (dba Meta Pharmacy Services), Las Vegas, NV - 503A Facility

483 Issued 12/09/2022 (PDF - 1.6MB)
483 Issued 12/14/2018 (PDF - 1.5MB)
483 Issued 12/20/2016 (PDF - 3MB)

Baycare Integrated Service Center, LLC dba BayCare Central Pharmacy, Temple Terrace, FL - 503B Facility

483 Issued 06/02/2023 (PDF - 194 KB)
FMD-145 Letter Issued 04/04/2022
483 Issued 12/10/2019 (PDF - 951KB)

Bayview Pharmacy, Inc., Saunderstown, RI - 503A Facility

Referral to the Rhode Island State Board of Pharmacy Issued 07/25/2017 (PDF - 79KB)
483 Issued 8/18/2016 (PDF - 769KB)

BBS Pharmacy, Inc. (dba B&B Pharmacy), formerly Pacific Healthcare, Inc., Bellflower, CA - 503A Facility

FMD-145 Letter Issued 08/31/2017 (PDF - 54KB)
Referral Letter to the California State Board of Pharmacy Issued 08/31/2017 (PDF - 52KB)
Warning Letter (09/02/2016)
483 Response Dated 09/09/2015 (PDF - 2.2MB)
Amended 483 Issued 08/18/2015 (PDF - 1.7MB)
483 Issued 08/18/2015 (PDF - 2.2MB)

Beacon Hill Medical Pharmacy, P.C. (dba Rxtra Solutions), Southfield, MI - 503A Facility

Warning Letter (09/24/2014)
Firm Press Release: Beacon Hill Medical Pharmacy, P.C. (dba Rxtra Solutions) Issues Voluntary Nationwide Recall of Certain Sterile Products Due to a Question of Sterility Assurance (07/31/2013)
483 Issued 07/19/2013 (PDF – 2.7MB)

Beacon Prescriptions (see DCA Inc.), Southington, CT - 503A Facility

Bedford Pharmacy, Inc. (dba Mytilini Enterprises LLC), Bedford, NH - 503A Facility

Untitled Letter Issued 10/4/2019 (PDF-100KB)
Firm response to 483 dated 09/22/2017 (PDF - 1MB)
483 Issued 08/17/2017 (PDF - 953KB)
Warning Letter (05/18/2016)
483 Issued 08/28/2015 (PDF - 776KB)

Bella Pharmaceuticals, Inc., Glenview, IL - 503A Facility - Ceased Compounding Operations

Warning Letter (02/11/2019)
Firm Press Release: Bella Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of All Sterile Drug Products Due to Lack of Sterility Assurance (8/18/2017)
483 Issued 07/28/2017 (PDF - 1.9 MB)
483 Issued 07/25/2017 (PDF - 1.9 MB)

Bellevue Pharmacy Solutions, St Louis, MO - 503A Facility

Warning Letter (01/14/2008)

Belmar Pharmacy, Lakewood, CO - 503A Facility

State Referral Letter Issued 12/05/2016 (PDF - 82KB)
483 Issued 06/18/2015 (PDF - 1.13MB)

Belmar Select Outsourcing, (see BSO, LLC), Lakewood, CO - 503B Facility

Best Value Drug, (see Farmville Discount Drug, Inc.), Farmville, NC - 503A Facility

Be Well Natural Medicine, Mill Valley, CA - 503A Facility

FMD-145 Letter Issued 08/15/2023
483 Issued 05/20/2022 (PDF - 703KB)

Bhaumik Diversified LLC dba Texas Star Pharmacy, Dallas, TX - 503A Facility

FMD-145 Letter Issued 1/17/2023
483 issued 11/3/2021 (PDF - 1.5MB)

Biomed PA Inc. (dba Soleo Health), Sharon Hill, PA - 503A Facility

FMD-145 Letter Issued 08/30/2012
State Referral Letter Issued 05/14/2018 (PDF - 75KB)
FMD-145 Letter Issued 08/30/2017 (PDF - 49KB)
483 Issued 07/06/2017 (PDF - 280KB)

Bioscrip Infusion Services, (see HomeChoice Partners, Inc.), Augusta, GA - 503A Facility

Bioscrip Infusion Services, (see InfuScience, Inc.), Chantilly, VA - 503A Facility

BioScrip Pharmacy (NY), Inc., Lake Success, NY - 503A Facility

Referral to the New York State Board of Pharmacy Issued 11/16/2017 (PDF - 93KB)
483 Response Dated 02/10/2015 (PDF - 7.6MB)
483 Response Dated 10/10/2014 (PDF - 1.3MB)
483 Issued 09/19/2014 (PDF - 1.9MB)

Blount Discount Pharmacy, Inc., Alcoa, TN - 503A Facility

FMD-145 Letter Issued 12/17/2021
Untitled Letter Issued 06/17/2021 (PDF - 1MB)
483 Issued 02/13/2020 (PDF - 1.55MB)

Blue Ridge Pharmacy and Compounding Center, Raleigh, NC - 503A Facility

FMD-145 Letter Issued 07/08/2016
Warning Letter (04/30/2014)
483 Issued 10/23/2013 (PDF – 589KB)

BMD Skincare, Inc., Canoga Park, CA - 503A Facility - Out of business

483 Issued 03/05/2019 (PDF - 15.6MB)

Bond Pharmacy, Inc. (dba Advanced Infusion Solutions), Clinton, MS - 503A Facility

Referral Letter to the Mississippi Board of Pharmacy Issued 08/02/2016 (PDF - 407KB)
483 Response Dated 11/16/2015 (PDF - 1.3MB)
483 Issued 10/27/2015 (PDF - 945KB)

Bond Pharmacy, Inc. (dba Advanced Infusion Solutions), Ridgeland, MS - 503A Facility

FMD-145 Issued 04/20/2018 (PDF - 45KB)
Warning Letter Response Dated 03/23/2017
Warning Letter (03/01/2017)
483 Response Dated 11/16/2015 (PDF - 1.3MB)
483 Issued 10/27/2015 (PDF - 1.7MB)

Bond Pharmacy, Inc. (dba Advanced Infusion Solutions), Dallas, TX - 503A Facility

483 Issued 01/30/2023 (PDF - 491KB)

Boothwyn Pharmacy LLC, Kennett Square, PA - 503A Facility

483 Issued 06/16/2017 (PDF - 736KB)

Botrosons Pharmaceutical Inc., (dba Tower Pharmacy and Compounding), Mission Viejo, CA - 503A Facility

FMD-145 Letter Issued 03/24/2022
Untitled Letter Issued 10/20/2021 (PDF - 201KB)
483 Issued 09/19/2019 (PDF - 1.05MB)

BPI Labs, LLC, Largo, FL - 503B Facility

FMD-145 Letter Issued 09/01/2021
483 Issued 04/30/2021 (PDF - 2.17MB)

brandMD Skin Care, (see TSDR Pharmacy, Inc.), Chatsworth, CA - 503A Facility

Brookfield Pharmacy, Brookfield, CT - 503A Facility

FMD-145 Letter Issued 05/22/2019
483 Issued 06/28/2017 (PDF - 2.1 MB)

Brookfield Medical/Surgical Supply, Inc., Brookfield, CT - 503B Facility

FMD-145 Letter Issued 02/06/2023
483 Issued 04/04/2022 (PDF - 4.6MB)
483 Issued 12/21/2018 (PDF - 1.12MB)
Amended 483 Issued 04/18/2017 (PDF - 859KB)
483 Issued 04/18/2017 (PDF - 872KB)
Warning Letter (07/05/2016)
483 Issued 04/09/2015 (PDF - 1.7MB)

Brookfield Prescription Center, Inc. (dba MD Custom Rx), Brookfield, WI - 503A Facility

Warning Letter (05/02/2014)
483 Issued 12/13/2013 (PDF – 5MB)

Brookhaven Milling Company, Brookhaven, MS

Untitled Letter Issued 10/18/2022 (PDF - 321KB)

Brown's Compounding Center, Inc., Englewood, CO - 503A Facility - Out of business

Warning Letter (08/17/2016)
483 Issued 04/27/2015 (PDF - 604KB)
483 Issued 08/11/2014 (PDF - 580KB)

BSO LLC (dba Belmar Select Outsourcing), Lakewood, CO - 503B Facility

FMD-145 Letter Issued 9/15/21
483 Issued 03/11/2021 (PDF - 1.1MB)
FMD-145 Letter Issued 6/22/2020 (PFD-60KB)
483 Issued 09/20/2019 (PDF - 265KB)
Untitled Letter Issued 01/10/2019 (PDF - 698KB)
483 Issued 09/02/2016 (PDF - 457KB)

Buderer Drug Company Inc. Avon, OH - 503A Facility

Referral Letter to the Ohio State Board of Pharmacy Issued 10/29/2019 (PDF - 126KB)
FMD-145 Letter Issued 10/21/2019 (PDF - 106KB)
483 Response Letter Dated 03/15/2019 (PDF - 679KB)
483 Issued 02/14/2019 (PDF - 268KB)

Buderer Drug Company Inc. Perrysburg, OH - 503A Facility

Referral Letter to the Ohio State Board of Pharmacy Issued 05/01/2019 (PDF - 98KB)
Warning Letter CloseOut (05/01/2019)
FMD-145 Letter Issued 05/01/2019 (PDF - 105KB)
483 Issued 07/24/2017 (PDF - 257KB)
Warning Letter (09/20/2016)
483 Issued 01/04/2016 (PDF - 402KB)

Buffalo Pharmacies, Inc., East Amherst, NY - 503A Facility

State Referral Letter Issued 9/16/2019 (PDF - 127KB)
FMD-145 Letter Issued 9/16/2019 (PDF - 105KB)
483 Issued 07/26/2018 (PDF - 157KB)
Warning Letter (12/13/2017)
483 Issued 06/23/2017 (PDF - 690KB)

Burklow Pharmacy, Inc., Pace, FL - 503A Facility

FMD-145 Letter Issued 04/05/2017 (PDF - 169KB)
Referral Letter to the Florida Board of Pharmacy Issued on 01/31/17 (PDF - 193KB)
483 Issued 03/04/2015 (PDF - 53KB)

Burt's Pharmacy LLC, Newbury Park, CA - 503A Facility

Referral Letter to the California State Board of Pharmacy Issued 05/23/2023 (PDF - 301KB)
483 Issued 10/07/2022 (PDF - 5.63MB)

California Pharmacy and Compounding Center, Newport Beach, CA - 503A Facility - De-registered as an Outsourcing Facility

FMD-145 Letter Issued 02/24/2020
Amended 483 Issued 12/18/2018 (PDF - 196KB)
483 Issued 04/21/2017 (PDF - 833KB)
483 Issued 08/31/2016 (PDF - 919KB)
Warning Letter (06/17/2015)
483 Issued 10/17/2014 (PDF - 544KB)
483 Issued 08/25/2014 (PDF - 2.8MB)

California Specialty Pharmacy, Inc., Whittier, CA - 503A Facility

FMD-145 Letter Issued 11/16/2020
Untitled Letter Issued 05/20/2020 (PDF - 204KB)
483 Issued 05/17/2019 (PDF - 397KB)

Cantrell Drug Company, Little Rock, AR - 503A Facility - Out of business

483 Issued 08/22/2018 (PDF - 466KB)
483 issued 03/22/2018 (PDF - 1.3MB)
FDA Press Release: Federal Judge Enters Consent Decree Against Cantrell Drug Company (04/19/2018)
FDA Press Release: FDA Alerts Health Care Professionals and Patients not to Use Compounded Drugs from Cantrell Drug Company; Agency Seeks Action to Stop Production and Distribution (03/01/2018)
Firm Press Release: Cantrell Drug Company Issues Voluntary Nationwide Recall of All Sterile Drug Products Due to Lack of Sterility Assurance (07/25/2017)
483 Issued 06/29/2017 (PDF - 3MB)
Firm Press Release: Sterile Drug Products by Cantrell Drug Company: Recall of Select Sterile Drug Products Due to Lack of Sterility Assurance (11/18/2016)
Second Amended 483 Issued 10/14/2016 (PDF - 4.5MB)
Amended 483 Issued 10/14/2016 (PDF - 4.5MB)
483 Issued 10/14/2016 (PDF - 4.5MB)
Company Response Letter 02/10/2015
Warning Letter (01/21/2015)
Amended 483 Issued 11/4/2013 (PDF - 6.5MB)

Cape Drugs, (see Valgene Incorporated), Annapolis, MD - 503A Facility

CareFirst Specialty Pharmacy LLC, Mount Laurel, NJ - 503A Facility

FMD-145 Letter Issued 03/31/2023
State Referral Letter (PDF - 263 KB)
483 Issued 11/30/2022 (PDF - 285 KB)

Carepoint Healthcare, LLC (dba Carepoint Pharmacy), Schaumburg, IL - 503A Facility

FMD-145 Letter Issued 06/19/2018 (PDF - 232KB)
State Referral Letter Issued 06/19/2018 (PDF - 181KB)
483 Issued 08/24/2017 (PDF - 947KB)

Care Solutions, Inc., Nashville, TN - 503A Facility

FMD-145 Issued 08/02/2018 (PDF - 48KB)

Carlton’s Dunwoody Pharmacy Corp, (dba Concord, Inc.), Dunwoody, GA - 503A Facility

Referral Letter to the Georgia State Board of Pharmacy Issued 11/18/2019 (PDF - 68 KB)
FMD-145 Letter Issued 11/18/2019 (PDF - 66 KB)
483 Issued 04/12/2019 (PDF - 79 KB)
Warning Letter (08/20/2017)
483 Issued 01/13/2016 (PDF - 714 KB)

Carolina Infusion, Ridgeland, SC - 503A Facility

Warning Letter (05/22/2023)
483 Issued 08/12/2022 (PDF - 918KB)

Cascade Specialty Pharmacy, (see Poulsbo Compounding Pharmacy, LLC), Poulsbo, WA - 503A Facility

Central Admixture Pharmacy Services, Inc. (CAPS), Homewood, AL - 503A Facility

483 Issued 03/07/2013 (PDF - 600KB)

Central Admixture Pharmacy Services, Inc., Phoenix, AZ - 503B Facility

FMD-145 Letter Issued 1/18/2023
483 Issued 02/25/2022 (PDF - 2 MB)
FMD-145 Letter Issued 06/03/2020 (PDF - 57 KB)

Central Admixture Pharmacy Services, Inc. Irvine, CA - 503A Facility

FMD-145 Letter Issued 05/03/2017 (PDF - 447KB)
483 Issued 02/05/2016 (PDF - 448KB)

Central Admixture Pharmacy Services, Inc. (CAPS), San Diego, CA - 503B Facility

FMD-145 Letter Issued 05/27/2020 (PDF - 72 KB)
483 Issued 09/11/2018 (PDF - 792 KB)
Warning Letter (08/18/2016)
483 Issued 08/08/2014 (PDF - 1 MB)

Central Admixture Pharmacy Services (CAPS), Wallingford, CT - 503A Facility

Referral to the Connecticut State Board of Pharmacy Issued 07/12/2017 (PDF - 52 KB)
483 Issued 01/29/2016 (PDF - 2 MB)
483 Issued 02/19/2013 (PDF - 8 MB)

Central Admixture Pharmacy Services, Inc., (CAPS), Chicago, IL - 503A Facility

483 Issued 02/22/2013 (PDF - 974 KB)

Central Admixture Pharmacy Services, Inc. (CAPS), Harahan, LA - 503A Facility

Referral Letter to the Louisiana Board of Pharmacy Issued 11/03/2022 (PDF - 190 KB)
FMD-145 Letter Issued 11/03/2022
Untitled Letter Issued 03/25/2022 (PDF - 754KB)
483 Issued 05/24/2021 (PDF - 731KB)

Central Admixture Pharmacy Services, Inc. (CAPS), Woburn, MA - 503A Facility

483 Issued 02/20/2014 (PDF - 1.9MB)
483 Issued 01/29/2013 (PDF - 11.7MB)

Central Admixture Pharmacy Services, Inc., (CAPS), Livonia, MI - 503A Facility

Referral Letter to the Michigan Board of Pharmacy Issued 03/22/2017 (PDF - 461KB)
483 Issued 12/04/2015 (PDF - 922KB)
483 Issued 06/25/2014 (PDF - 928KB)
483 Issued 02/28/2013 (PDF - 790KB)

Central Admixture Pharmacy Services, Inc., (CAPS), Kansas City, MO - 503A Facility

483 Issued 02/28/2013 (PDF - 697KB)

Central Admixture Pharmacy Services Inc. Valley View, OH - 503A Facility

Referral Letter to the Ohio State Board of Pharmacy Issued 08/09/17 (PDF - 101KB)
483 Issued 01/21/2016 (PDF - 876KB)

Central Admixture Pharmacy Services, Inc. (CAPS), Allentown, PA - 503B Facility

483 Issued 03/30/2023 (PDF - 1.53 MB)
FMD-145 Letter Issued 06/17/2020 (PDF - 74KB)
483 Issued 08/22/2018 (PDF - 2.1MB)
483 Issued 09/19/2016 (PDF - 898KB)
Warning Letter (08/19/2016)
483 Issued 02/11/2015 (PDF - 888KB)
483 Issued 06/11/2014 (PDF - 2.1MB)

Central Admixture Pharmacy Services, Inc. (CAPS), Cranberry Township, PA - 503A Facility

FMD-145 issued 10/11/2022
483 Issued 05/04/2022 (PDF - 5.91MB)

Central Admixture Pharmacy Services, Inc. (CAPS), Horsham, PA - 503A Facility

Referral Letter to the Pennsylvania State Board of Pharmacy Issued 01/17/17 (PDF - 335KB)
483 Issued 11/20/2015 (PDF - 595KB)

Central Illinois Compounding, Inc. (dba Preckshot Professional Pharmacy), Peoria Heights, IL - 503A Facility

Amended 483 issued 08/10/2018 (PDF - 752KB)
483 issued 08/10/2018 (PDF - 723KB)
483 Issued (9/19/2017)
Warning Letter (09/02/2016)
483 Issued 05/14/2015 (PDF - 910KB)

CFP Acquisitions, Inc, Tulsa, OK - 503A Facility

FMD-145 Letter Issued 03/07/2023
483 Issued 01/18/2022 (PDF - 706KB)
483 Issued 07/11/2018 (PDF - 511KB)

Chastains, Inc., (dba Owl Tri State Pharmacy), Clarkston, WA - 503A Facility

FMD-145 Letter Issued 01/21/2022
483 Issued 08/27/2021 (PDF - 345KB)

Chen Shwezin, Inc., (dba Park Compounding Pharmacy), Westlake Village, CA - 503A Facility

FMD-145 Letter Issued 07/20/2020 (PDF - 62KB)
Referral Letter to the California State Board of Pharmacy Issued 07/20/2020 (PDF - 58KB)
483 Issued 04/03/2018 (PDF - 778KB)
Warning Letter (03/15/2017)
FDA Statement: FDA Alerts Health Care Professionals and Patients not to Use Sterile Drug Products from Chen Shwezin Inc., dba Park Compounding Pharmacy (10/2/2015)
483 Issued 09/11/2015 (PDF - 1.4MB)

Cincinnati Specialty Pharmacy LLC, West Chester, OH - 503A Facility

FMD-145 Letter Issued 07/10/2017
State Referral Letter Issued 07/10/2017 (PDF - 61KB)
483 Issued 09/26/2016 (PDF - 533KB)

Civic Center Pharmacy, Scottsdale, AZ - 503A Facility

FMD-145 Letter Issued 04/02/2019
483 Issued 03/30/2017 (PDF - 469KB)
Warning Letter (08/20/2015)
483 Response Dated 10/10/2014 (PDF - 2.2MB)
483 Issued 10/09/2014
Warning Letter (12/16/2008)

Claremore Compounding Center, Inc., Claremore, OK - 503A Facility

FMD-145 Letter Issued 04/29/2021
Untitled Letter Issued 08/21/2020 (PDF - 1.63MB)
483 Issued 01/24/2020 (PDF - 3.76MB)

Clark Professional Pharmacy, LLC, Ann Arbor, MI - 503A Facility

Referral Letter to the Michigan Board of Pharmacy Issued 09/09/16 (PDF - 429KB)
483 Response Dated 02/11/2016 (PDF - 2.3MB)
483 Issued 01/29/2016 (PDF - 225KB)

Clinical Apothecaries, Medina, OH - 503A Facility

Referral Letter to the Ohio Board of Pharmacy Issued 05/30/2014 (PDF - 1.1MB)
483 Issued 11/20/2013 (PDF - 660KB)

Clinical Specialties Compounding Pharmacy, Augusta, GA - 503A Facility - Out of business

Warning Letter (06/27/2014)
483 Issued 04/02/2013 (PDF - 5.4MB)
FDA Press Release: FDA Alerts Health Care Providers and Patients of the Nationwide Recall of All Lots of Sterile Products Distributed by Clinical Specialties Compounding Pharmacy (03/21/2013)
Firm Press Release: Clinical Specialties Compounding Pharmacy Recalls All lots of Sterile Products Repackaged and Distributed by Clinical Specialties Compounding Due to Lack of Sterility Assurance (03/20/2013)

CMC Enterprise Pharmacy, Charlotte, NC - 503A Facility - Out of business

FMD-145 Letter Issued 07/17/2020
FMD-145 Letter Issued 07/17/2020 (PDF - 190KB)
Warning Letter (06/04/2020)

Coastal Meds, LLC., Biloxi, MS - 503A Facility

FMD-145 Letter Issued 11/05/2019 (PDF - 67KB)
Referral Letter to the Mississippi State Board of Pharmacy Issued 11/05/2019 – Shutdown Letter (PDF - 97KB)
FDA Statement: FDA Alerts Health Care Professionals to Voluntary Nationwide Recall of All Sterile Products from Coastal Meds (4/13/18)
483 Issued 04/06/2018 (PDF - 1.2MB)
Warning Letter (06/22/2016)
483 Issued 09/23/2015 (PDF - 1.1MB)
483 Issued 11/10/2014 (PDF - 691KB)

Coast Quality Pharmacy, LLC, Tampa, FL - 503A Facility

FMD-145 Letter Issued 06/29/2022
483 Issued 05/09/2019 (PDF - 1.16MB)
483 Issued 05/07/2018 (PDF - 2.6MB)

College Pharmacy Incorporated, Colorado Springs, CO - 503A Facility

FMD-145 Letter Issued 07/19/2022
483 Issued 01/17/2018 (PDF - 1MB)
Warning Letter (08/15/2016)
483 Issued 05/28/2015 (PDF - 1MB)
483 Issued 03/15/2013 (PDF - 1.3MB)

Colonia Care Pharmacy, Colonia, NJ - 503A Facility

483 Response Dated 08/17/2021 (PDF - 718KB)
483 Issued 07/26/2021 (PDF - 736KB)
483 Issued 04/29/2019 (PDF - 601KB)
Warning Letter (09/20/2017)
483 Response Dated 05/05/2016 (PDF - 969KB)
483 Issued 04/15/2016 (PDF - 708KB)

Columbia River Pharmacy, LLC, (dba Malley's Compounding Pharmacy), Richland, WA - 503A Facility

FMD-145 Letter Issued 07/19/2021
483 Issued 08/16/2019 (PDF - 281KB)

Complete Pharmacy and Medical Solutions, LLC, Miami Lakes, FL - 503A Facility - De-registered as an Outsourcing Facility

Compound Care Pharmacy, Louisville, KY - 503A Facility

FMD-145 Letter Issued 06/04/2020 (PDF - 106KB)
483 Issued 05/16/2019 (PDF - 169KB)

Compounded Solutions in Pharmacy LLC, Monroe CT - 503A Facility

483 Issued 07/27/2021 (PDF - 966KB)
Warning Letter (09/18/2017)
483 Issued 03/03/2017 (PDF - 567KB)

Compounding Pharmacies of Louisiana Inc. (dba Professional Arts Pharmacy), Lafayette, LA - 503A Facility

Closeout Letter Issued 10/17/2016 (PDF - 208KB)

Compound Preferred LLC, Idaho Falls, ID - 503B Facility

483 Issued 12/17/2021 (PDF - 2.57MB)

Concord, Inc. (see Carlton's Dunwoody Pharmacy), Dunwoody, GA - 503A Facility

Conrad-Marr Drug, (see McAlister Drug Corporation), Yukon, OK - 503A Facility

Conversio Health, (see Integrated Health Concepts Inc.), San Luis Obispo, CA - 503A Facility

Coram Healthcare Corp. of Indiana, Crown Point, IN - 503A Facility - Out of business

FMD-145 Letter Issued 03/07/2019 (PDF - 89KB)
Facility Closure Letter 05/29/2018 (PDF - 125KB)
483 Firm Response Dated 05/16/2017 (PDF - 951KB)
483 Issued 04/26/2017 (PDF - 503KB)
Warning Letter (08/11/2015)
483 Issued 12/16/2014

Cortez Drugs, (see A Chem Rx, LLC), Brooksville, FL - 503A Facility

Crawford's Professional Drugs, Inc., (dba Diket's Professional Drugs, Inc.), Laurel, MS - 503A Facility

Referral Letter to the Mississippi Board of Pharmacy Issued 06/27/2019 (PDF - 59KB)
FMD-145 Letter Issued 06/27/2019 (PDF - 64KB)
483 Issued 11/29/2018 (PDF - 574KB)

CRC Pharmacy, Roswell, GA - 503A Facility

Referral Letter to the Georgia State Board of Pharmacy Issued 02/15/2017 (PDF - 195KB)

Creative Compounds, (see Oregon Compounding Centers, Inc.), Wilsonville, OR - 503A Facility

Crosby’s Drugs Inc., Columbus, OH - 503A Facility

483 Issued 09/30/2021 (PDF - 1.36MB)
Warning Letter (11/30/2017)
483 Issued 09/16/2016 (PDF - 612KB)

Crowder's Institutional Pharmacy LLC., dba Crowder's Long-Term Care Pharmacy, Bedford, IN - 503A Facility

Referral Letter to the Indiana State Board of Pharmacy Issued 10/02/2019 (PDF - 579KB)
FMD-145 Letter Issued 10/02/2019 (PDF - 513KB)

CSRX Inc., (dba Rushmore Compounding Pharmacy), Rapid City, SD - 503A Facility

FMD-145 Letter Issued 02/19/2019 (PDF - 66KB)
Untitled Letter Issued 12/20/2017 (PDF - 314KB)

Curexa, (see EHT Pharmacy LLC), Egg Harbor Township, NJ - 503A Facility

Customceutical Compounding, LLC, Phoenix, AZ - 503A Facility

Warning Letter (08/25/2020)
483 Issued 03/08/2019 (PDF - 957KB)

Custom Compounding Center, Little Rock, AR - 503A Facility

Referral Letter to the Arkansas State Board of Pharmacy Issued 10/28/2020 (PDF - 435KB)
483 Issued 06/04/2019 (PDF - 196KB)
Warning Letter (03/16/2016)
483 Issued 04/09/2015 (PDF - 603KB)

Custom Compounding Centers, LLC, Los Alamitos, CA - 503A Facility

Referral Letter to the California State Board of Pharmacy Issued 12/14/2015 (PDF - 120KB)
483 Response Dated 10/17/2014 (PDF - 637KB)
483 Response Dated 10/09/2014 (PDF - 225KB)
483 Response Dated 09/18/2014 (PDF - 844KB)
483 Issued 08/28/2014 (PDF - 457KB)
Warning Letter (05/15/2013)
483 Issued 12/13/2012 (PDF - 577KB)

Custom Meds Inc. Inverness, FL - 503A Facility

Closeout Letter Issued 07/21/2016 (PDF - 388KB)
483 Issued 03/25/2016 (PDF - 429KB)

Custom RX LLC, Wichita, KS - 503A Facility

FMD-145 Letter Issued 01/20/2022
Warning Letter (10/18/2018)
483 Issued 08/15/2017 (PDF -331KB)

Custom RX LLC (dba Custom RX Compounding Pharmacy), Richfield, MN - 503A Facility

483 Issued 08/28/2014 (PDF - 775KB)

D&D Pharma, LLC (dba MedScript Compounding Pharmacy), Noblesville, IN - 503A Facility

FMD-145 Letter Issued 03/05/2020 (PDF - 116KB)
483 Issued 07/17/2019 (PDF - 458KB)

D&S Enterprises, LLC (dba Miller’s Health Mart Pharmacy), Vero Beach, FL - 503A Facility

FMD-145 Letter Issued 03/16/2018 (PDF - 63KB)
483 Issued 08/09/2017 (PDF - 205KB)

Davis City Pharmacy, Inc., Weatherford, TX

Referral Letter to the Texas State Board of Pharmacy Issued 11/30/2022 (PDF - 287KB)
FMD-145 Issued 11/30/2022
Untitled Letter Issued 08/05/2022 (PDF - 157KB)
483 Issued 02/18/2022 (PDF - 883KB)

DCA Inc. (dba Beacon Prescriptions), Southington, CT - 503A Facility

Warning Letter (6/1/2017)
4 83 Issued 10/25/2016 (PDF - 816KB)

Delta Pharma, Inc., Ripley, MS - 503B Facility

483 Issued 06/02/2023 (PDF - 229KB)
483 Issued 05/20/2022 (PDF - 1.57MB)
FDA Press Release: Federal judge enters consent decree against Delta Pharma (06/08/2018)
483 Issued 02/23/2017 (PDF - 1.4MB)
483 Issued 05/24/2016 (PDF - 1013KB)
Warning Letter (12/09/2014)
483 Issued 10/02/2013 (PDF - 857KB)

Denson's Specialty Pharmacy, (see Wellcare Rx Investments LLC), Wheaton, IL - 503A Facility

Denver Solutions, LLC (dba Leiter's Health), Englewood, CO - 503B Facility

FMD-145 Letter Issued 03/29/2022
483 Issued 10/07/2021 (PDF - 8.94MB)
483 Issued 07/18/2019 (PDF - 606KB)
FMD-145 Letter Issued 10/18/2018 (PDF - 54KB)
483 Issued 02/23/2018 (PDF - 654KB)

Designer Drugs, (see The Wellness Center Pharmacy, Inc.), Chattanooga, TN - 503A Facility

Diabetes Corporation of America, Franklin, TN - 503A Facility

State Referral Letter Issued 02/19/2018 (PDF - 71KB)
FMD-145 Letter Issued 02/19/2018 (PDF - 63KB)
483 Issued 06/15/2017 (PDF - 406 KB)
Warning Letter (06/03/2016)
483 Issued 08/20/2015 (PDF - 741 KB)

Diamond Drugs, Inc., (dba Diamond Pharmacy Services), Indiana, PA - 503A Facility

FMD-145 Letter Issued 07/20/2018 (PDF - 72KB)
State Referral Letter Issued 07/20/2018 (PDF - 70KB)
483 Issued 07/21/2017 (PDF - 197KB)

Diamond Pharmacy, LLC, Houston, TX - 503A Facility

DOJ Press Release: Leader of $17 Million Health Insurance Fraud Scheme Ordered to Prison (July 27, 2017)
483 Issued 05/15/2015 (PDF - 1.8 MB)

Dignity Health- Northridge Hospital Medical Center, Northridge, CA - 503A Facility

483 Issued 11/07/2017 (PDF - 1.2MB)
Warning Letter (12/13/2016)
483 Issued 03/11/2016 (PDF - 1.1MB)

Diket's Professional Drugs, Inc., (see Crawford's Professional Drugs, Inc.), Laurel, MS - 503A Facility

Diplomat Pharmacy, Inc. (dba Diplomat Specialty Pharmacy), Flint, MI - 503A Facility

State Referral Letter Issued 02/11/2019 (PDF - 75KB)
FMD-145 Letter Issued 02/11/2019 (PDF - 70KB)
483 Issued 11/17/2017 (PDF - 722KB)

Diversified Pharmacy Inc., (dba University Compounding Pharmacy), Troy, MI - 503A Facility

FMD-145 Letter Issued 11/01/2018 (PDF - 69KB)
State Referral Letter Issued 11/01/2018 (PDF - 109KB)
483 Issued 06/19/2017 (PDF - 431KB)
Warning Letter (02/26/2016)
483 Response Dated 12/02/2014 (PDF - 1.6MB)
483 Issued 11/13/2014 (PDF - 869KB)

DNA Pharmacy Services, Inc. (dba Palm Beach Compounding), Jupiter, FL - 503A Facility - Ceased sterile compounding

483 Issued 05/23/2017 (PDF - 33KB)
483 Issued 08/13/2014 (PDF - 251KB)

Dorneyville Pharmacy, Allentown, PA - 503A Facility

FMD-145 Letter Issued 6/22/2020 (PDF-103KB)
Untitled Letter Issued 03/04/2020 (PDF - 321KB)
483 Issued 09/28/2018 (PDF - 223KB)
Warning Letter (02/07/2017)
483 Issued 01/07/2016 (PDF - 2.1MB)

Dougherty's Pharmacy, Dallas, TX - 503A Facility

FMD-145 Letter Issued 05/18/2020 (PDF - 70KB)
Referral Letter to the Texas State Board of Pharmacy Issued 05/18/2020 (PDF - 75KB)
483 Issued 07/01/2019 (PDF - 1.28MB)
483 Issued 12/29/2015 (PDF - 2.1MB)
Warning Letter (05/12/2017)

Downing Labs, LLC, (formerly NuVision Pharmacy), Dallas, TX - 503A Facility - Out of business

FMD-145 Letter Issued 08/06/2019 (PDF - 74KB)
483 Issued 11/19/2018 (PDF - 416KB)
FDA Press Release: Federal Judge Enters Consent Decree Against Downing Labs (01/11/2016)
Firm Press Release: Downing Labs, LLC Issues Voluntary Nationwide Recall of All Sterile Compounded Products Due to Lack of Sterility Assurance (10/20/2015)
483 Issued 10/09/2015 (PDF - 8.9MB)
FDA Requested Recall Letter Issued 09/09/2014 (PDF – 941KB)
FDA Press Release: FDA Reminds Health Care Professionals and Consumers not to Use Sterile Products from Downing Labs/NuVision Pharmacy of Texas (09/09/2014)
483 Response Dated 08/20/2014 (PDF - 4.2MB)
483 Response Dated 08/06/2014 (PDF - 4MB)
FDA Statement: FDA Alerts Health Care Professionals not to Use Sterile Drugs from Downing Labs (aka NuVision Pharmacy) (07/18/2014)
483 Issued 07/16/2014 (PDF - 2.1MB)
FDA Press Release: FDA Reminds Health Care Providers not to Use Sterile Products from NuVision Pharmacy (08/16/2013)
FDA Requested Recall Letter Issued 07/26/2013 (PDF – 862KB)
FDA Press Release: FDA Expands Alert to Health Care Providers About Lack of Sterility Assurance of All Sterile Drug Products from NuVision Pharmacy (05/18/2013)
483 Issued 04/17/2013 (PDF - 1.2MB)
Firm Press Release: NuVision Pharmacy Recalls All Lots of All Lyophilized Products Compounded by NuVision Pharmacy Due to Sterility Assurance Concerns (04/15/2013)
FDA Press Release: FDA Issues Alert About Lack of Sterility Assurance of Drug Products from ApotheCure, Inc. and NuVision Pharmacy and of Forthcoming Recall (04/15/2013)

D.R. Pharmacy, Inc., Midland, TX - 503A Facility

483 Issued 03/06/2015 (PDF - 647KB)

Drug Crafters, L.P., Frisco, TX - 503A Facility

State Referral Letter Issued 02/11/2019 (PDF - 67KB)
483 Issued 07/11/2018 (PDF - 340 KB)

Drug Depot Inc. (dba APS Pharmacy), Palm Harbor, FL - 503A Facility

483 Issued 06/17/2022 (PDF - 670KB)
FDA Press Release: FDA alerts customers to voluntary recall of compounded drugs due to sterility issues by Drug Depot, LLC, dba APS Pharmacy (04/26/2022)
FMD-145 Letter Issued 09/20/2019 (PDF - 63KB)
483 Issued 07/13/2018 (PDF - 272KB)
Warning Letter (12/15/2016)
483 Issued 01/22/2016 (PDF - 1.7MB)

Drugs are Us, Inc. (dba Hopewell Pharmacy), Hopewell, NJ - 503A Facility

Referral Letter to New Jersey State Board of Pharmacy Issued 02/21/2014 (PDF - 1.3MB)
483 Response Dated 02/21/2014
483 Issued 03/21/2013 (PDF - 1.5MB)
Warning Letter (09/28/2009)

Duren's Health Mart Pharmacy, Waynesboro, TN - 503A Facility - Ceased Compounding Operations

483 Issued 11/14/2018 (PDF - 358KB)

Dynalabs LLC, Saint Louis, MO - 503A Facility

483 Issued 09/26/2019 (PDF - 2.07MB)

Eagle New York, Garfield, NJ - 503A Facility

Warning Letter (12/06/2013)

Eagle Pharmacy, Inc., Hoover, AL - 503B Facility

Untitled Letter Issued 05/17/2022 (PDF - 586KB)
483 Issued 08/12/2021 (PDF - 985KB)
483 Issued 05/18/2018 (PDF - 692KB)
Warning Letter (10/13/2016)
483 Issued 08/21/2015 (PDF - 1.2MB)

East Marietta Drug Company, Marietta, GA - 503A Facility

FMD-145 Letter Issued 05/19/2020 (PDF - 83KB)
Referral Letter to the Georgia State Board of Pharmacy Issued 05/19/2020 (PDF - 88KB)
483 Issued 08/23/2019 (PDF - 2.08MB)

Eastern Pharmacy, Inc., Ocala, FL - 503A Facility

Warning Letter (10/29/2014)
483 Issued 02/04/2014 (PDF - 516KB)

Eastern States Compounding Pharmacy, (see Northern New England Compounding Pharmacy), Littleton, NH - 503A Facility

Edge Pharmacy Services, LLC, Colchester, VT - 503B Facility

DOJ Press Release District Court Enjoins Vermont Pharmacy from Distributing Drugs Not Made in Compliance with FDCA (06/13/2022)
483 Issued 12/01/2021 (PDF - 6.45MB)
483 Issued 03/30/2020 (PDF - 3.6MB)
483 Issued 03/08/2018 (PDF - 3.5MB)
483 Issued 01/20/2017 (PDF - 717KB)
Warning Letter (11/12/2015)
483 Issued 08/20/2014 (PDF - 923KB)

EHT Pharmacy LLC, (dba Curexa), Egg Harbor Township, NJ - 503A Facility

483 Issued 09/09/2022 (PDF - 1.23MB)
483 Issued 10/09/2020 (PDF - 743KB)
483 Issued 09/27/2018 (PDF - 276KB)

Elkhart Pharmacy, Elkhart, TX - 503A Facility - Out of business

Warning Letter (05/08/2017)
483 Issued 12/21/2015 (PDF - 765KB)

Empower Clinic Services, LLC, Houston, TX - 503B Facility

483 Issued 08/05/2022 (PDF - 20.4MB)
Warning Letter (10/15/2021)
483 Issued 03/06/2020 (PDF - 1.02MB)
Untitled Letter Issued 07/22/2019 (PDF - 106KB)
FMD-145 Letter Issued 04/02/2019 (PDF - 51KB)
483 Issued 01/24/2018 (PDF - 650KB)
483 Issued 11/25/2015 (PDF - 971KB)
Warning Letter (05/25/2017)

Enclara Pharmacia Inc., Sharon Hill, PA - 503A Facility - Ceased sterile compounding

Warning Letter (03/29/2017)
483 Issued 06/06/2016 (PDF - 372KB)

Essential Pharmacy Compounding, Omaha, NE - 503A Facility

483 Issued (7/27/2017)
Warning Letter (03/10/2016)
483 Issued 05/22/2015 (PDF - 1.2MB)

Essential Wellness Pharma, (see Kalman Health & Wellness Inc.), Peoria, IL - 503A Facility

Everwell Specialty Pharmacy, Pensacola, FL (see Pensacola Apothecary Inc.) - 503A Facility

Exela Pharma Sciences, LLC, Lenoir, NC - 503B Facility

Warning Letter (04/08/2021)
483 Issued 07/18/2019 (PDF - 1.63MB)
FMD-145 Letter Issued 11/29/2018 (PDF - 38KB)
483 Issued 09/28/2017 (PDF - 665KB)
Firm Press Release: Exela Pharma Sciences, LLC Issues Voluntary Nationwide Recall of Ibuprofen Lysine Injection, 20 Mg/2 Ml (10 Mg/Ml) Due to Particulate Matter (02/08/2017)
Untitled Letter (04/28/2016)
483 Issued 11/21/2014 (PDF - 406KB)

Expert Compounding Pharmacy, Lake Balboa, CA - 503A Facility

FMD-145 Letter Issued 01/06/2023
Untitled Letter Issued 08/26/2022 (PDF - 635KB)
483 Issued 03/04/2022 (PDF - 1.12MB)

Fagron Compounding Services LLC (dba Fagron Sterile Services), Wichita, KS - 503B Facility

FMD-145 Letter Issued 11/21/2022
483 Issued 03/24/2022 (PDF - 7 MB)
483 Issued 06/21/2019 (PDF - 2 MB)
Firm Press Release: Fagron Sterile Services Issues Voluntary Nationwide Recall of Neostigmine Methylsulfate 1mg/mL, 5mg per 5mL and Neostigmine Methylsulfate 1mg/mL, 3mg per 3mL, in a 5mL syringe Due to Mislabeling (06/29/2018)
Warning Letter (11/28/2017)
Firm Press Release: Fagron Sterile Services Issues Voluntary Nationwide Recall of Succinylcholine Chloride Due to Potential For Lack of Sterility Assurance (06/23/2017)
483 Issued 09/21/2016 (PDF - 680 KB)
FDA Statement: FDA alerts compounding pharmacies of a nationwide voluntary recall of Syrspend SF and Syrspend SF Grape suspending agents from Fagron Inc., due to microbial contamination with yeast (02/10/2016)

Fairview Compounding Pharmacy, Minneapolis, MN - 503A Facility

FMD-145 Letter Issued 04/29/2019 (PDF - 95 KB)
Referral Letter to the Minnesota State Board of Pharmacy Issued 04/29/2019 (PDF - 122 KB)
Firm Response Dated 05/08/2018 (PDF - 738 KB)
483 Issued 04/18/2018 (PDF - 446 KB)

Fallon Wellness Pharmacy, LLC, Latham, NY - 503A Facility

FMD-145 Letter Issued 12/18/2018 (PDF - 74 KB)
Warning Letter Close Out Issued 12/18/2018
State Handoff Letter Issued 12/18/2018 (PDF - 114 KB)
483 Issued 12/06/2016 (PDF - 2 MB)
Warning Letter (02/01/2016)
483 Issued 03/10/2015 (PDF - 1MB)

Family Pharmacy of Statesville, Inc., Statesville, NC - 503A Facility

483 Issued 03/11/2022 (PDF - 923 KB)
Warning Letter (11/06/2020)
483 Issued 02/12/2020 (PDF - 878 KB)

Far Hills Pharmacy, (see Pharmaview, Inc.), Bedminster, NJ - 503A Facility

Farmacia Le Salud Inc., Caguas, PR - 503A Facility

Warning Letter (03/26/2008)

Farmakeio Outsourcing LLC, Southlake, TX - 503B Facility

Amended 483 Issued 6/14/2022 (PDF - 938 KB)
FDA Statement: FDA warns patients and health care professionals not to use sterile products from North American Custom Laboratories LLC, dba FarmaKeio Superior Custom Compounding (3/30/2022)
Warning Letter (07/29/2021)
483 Issued 10/30/2019 (PDF - 2.76MB)

Farmville Discount Drug, Inc., (dba Best Value Drug), Farmville, NC - 503A Facility - Out of business

Warning Letter (07/09/2019)

FH Investments Inc., (dba Asteria Health), Birmingham, AL - 503B Facility

FMD-145 Letter Issued 09/10/2021
483 Issued 07/10/2018 (PDF - 439KB)

First Call IV Pharmacy, LLC, Kenner, LA - 503A Facility

FMD-145 Letter issued 05/14/2018 (PDF - 47 KB)
State Referral Letter issued 05/14/2018 (PDF - 55 KB)
483 Issued 08/02/2017 (PDF - 550 KB)

First Pharma Associates LLC (dba Riverpoint Pharmacy), Spokane, WA - 503A Facility

Warning Letter Close Out Issued 09/13/2021
FMD-145 Letter Issued 09/13/2021
483 Issued 03/03/2021 (PDF - 381 KB)
483 Issued 06/07/2019 (PDF - 1 MB)
Warning Letter (09/12/2017)
483 Response Dated 01/09/17 (PDF - 396 KB)
483 Issued 12/16/2016 (PDF - 542 KB)

First Royal Care Co. LLC, (dba Red Mountain Compounding Pharmacy), Mesa, AZ - 503A Facility

FMD-145 Letter Issued 2/13/2023
Warning Letter Close Out Issued 02/13/2023
State Referral Letter Issued 02/13/2023 (PDF - 252 KB)
483 Issued 09/12/2022 (PDF - 2.98 MB)
483 Issued 08/11/2021 (PDF - 2 MB)
Warning Letter (09/08/2020)
Amended 483 Issued 12/12/2019 (PDF - 1.36 MB)
483 Issued 06/14/2019 (PDF - 1 MB)

Flourish Integrative Pharmacy, LLC, Oklahoma City, OK - 503A Facility

FMD-145 Letter Issued 04/15/2020 (PDF - 121 KB)
483 Issued 12/19/2018 (PDF - 341 KB)

Foothills Professional Pharmacy, Ltd., Phoenix, AZ - 503A Facility

Warning Letter Close Out Issued 03/16/2022
FMD-145 Letter Issued 03/16/2022
483 Issued 10/01/2021 (PDF - 501KB)
Warning Letter (09/09/2020)
Amended 483 Issued 12/17/2018 (PDF - 3.67 MB)
483 Issued 10/24/2018 (PDF - 1.1MB)

Foundation Care LLC, Earth City, MO - 503A Facility

Referral Letter to Missouri Board of Pharmacy Issued 02/26/2014 (PDF - 396KB)
483 Response Dated 04/09/2013 (PDF - 1020KB)
Amended 483 Issued 03/19/2013 (PDF - 867KB)

Franck's Compounding Lab (see Franck's Lab, Inc.), Ocala, FL - 503A Facility - Out of business

Franck's Lab, Inc. (dba Franck's Compounding Lab), Ocala, FL - 503A Facility - Out of business

FDA Press Release: Federal judge enters order of permanent injunction against Paul W. Franck (4/29/2016)
Warning Letter (07/09/2012)
Firm Press Release: All Sterile Human and Veterinary Prescriptions Distributed by Franck's Pharmacy from November 21, 2011 to May 21, 2012 (05/25/2012)
Firm Press Release: Notice of Recall - Triamcinolone acetonide P.F. 80mg/ml (05/02/2012)
FDA Statement: Updated: FDA Issues Second Warning to Physicians about Certain Compounded Drugs from Franck's (04/20/2012)
Firm Press Release: Notice of Recall (03/31/2012)
FDA Statement: FDA Warns Physicians about Using Brilliant Blue G for Eye Surgery (03/19/2012)
Firm Press Release: Recall of Brilliant Blue G Urgent Product Recall - Immediate Action Required (03/09/2012)

Franck's Lab, Inc. (dba Trinity Care Solutions), Ocala, FL - 503A Facility - Out of business

483 Issued 05/23/2014 (PDF - 856KB)

Freedom Fertility Pharmacy, (see Lynnfield Drug, Inc.), Byfield, MA - 503A Facility

Freedom Pharmacy, (see HHCS Pharmacy, Inc.), Orlando, FL - 503A Facility

Fresenius Kabi Compounding, LLC, Canton, MA - 503B Facility

FMD-145 Letter Issued 08/11/2023
483 Issued 03/06/2023 (PDF - 494KB)
FMD-145 Letter Issued 04/22/2020 (PDF - 88KB)
483 Issued 12/04/2018 (PDF - 2.9MB)

Front Door Pharmacy, LLC, (dba Pure Pharmacy), Houston, TX - 503A Facility

Warning Letter (07/01/2020)
483 Issued 03/18/2019 (PDF - 1MB)

Front Range Laboratories, Incorporated, Loveland, CO - 503A Facility

483 Issued 03/20/2020 (PDF - 589KB)

Fusion IV Pharmaceuticals Inc. (dba Axia Pharmaceuticals), Los Angeles, CA - 503A Facility - De-registered as an Outsourcing Facility

483 Issued 12/20/2019 (PDF - 3.5MB)
Warning Letter (02/21/2018)
Second Amended 483 Issued 03/23/2017 (PDF - 1.4MB)
Amended 483 Issued 03/23/2017 (PDF - 1.4MB)
483 Issued 03/23/2017 (PDF - 1.5MB)

FVS Holdings, Inc. (dba Green Valley Drugs), Henderson, NV - 503A Facility - Out of business

Warning Letter (08/30/2013)
Firm Press Release: Green Valley Drugs Announces Voluntary Nationwide Recall of All Lots of All Sterile Products Compounded, Repackaged, and Distributed by Green Valley Drugs Due to Quality Control Concerns (04/05/2013)
483 Issued 03/15/2013 (PDF - 4.9MB)

Garda Rx LLC., Apollo, PA - 503A Facility

FMD-145 Letter Issued 05/07/2018 (PDF - 71KB)
State Referral Letter Issued 05/07/2018 (PDF - 72KB)
483 Issued 06/06/2017 (PDF - 47 KB)

Geneva Woods Pharmacy, Anchorage, AK - 503A Facility

Referral Letter to the Alaska State Board of Pharmacy dated 02/18/2020 (PDF - 98KB)
FMD-145 Letter Issued 02/18/2020 (PDF - 79KB)
Referral Letter to the Alaska State Board of Pharmacy dated 02/06/2020 (PDF - 72KB)
FMD-145 Letter Issued 02/06/2020 (PDF - 62KB)
483 Issued 04/16/2019 (PDF - 411KB)
483 Issued 12/07/2018 (PDF - 1MB)

Gipsco Investment Corp. (dba Lee Silsby Compounding Pharmacy), Cleveland Heights, OH - 503A Facility

State Handoff Letter Issued 01/05/2023
FMD-145 Issued 01/05/2023
Warning Letter Close Out Issued 01/05/2023
Warning Letter (07/10/2018)
483 Issued 06/09/2017 (PDF - 1.29MB)

Glades Drugs, Pahokee, FL - 503A Facility

Good Day Pharmacy, (see Professional Pharmacy Services, Inc.), Loveland, CO - 503A Facility

Good Health Inc., (dba Premier Pharmacy Services), Baldwin Park, CA - 503A Facility

FMD-145 Letter Issued 12/06/2019
State Referral Letter Issued 12/06/2019
483 Issued 11/29/2018 (PDF - 379KB)

Grandpa's Compounding Pharmacy, Inc. Placerville, CA - 503A Facility - Out of business

483 Issued 09/18/2015 (PDF - 322KB)
Warning Letter (05/02/2014)
483 Issued 09/10/2013 (PDF - 1.1MB)

Green Hills Health and Wellness Pharmacy, Inc. (dba Health and Wellness Compounding Pharmacy), Nashville, TN - 503A Facility

FMD-145 Letter Issued 05/30/2017 (PDF - 54KB)
Referral Letter to the Tennessee Board of Pharmacy Issued 02/08/2017 (PDF - 403KB)
483 Issued 06/30/2016 (PDF - 516KB)
Warning Letter (06/04/2015)
483 Response Dated 11/11/2014 (PDF - 4.1MB)
483 Issued 10/22/2014 (PDF - 727KB)

Greenpark Compounding Pharmacy, (see Prescription Labs, Inc.), Houston, TX - 503A Facility

Green Valley Drugs, (see FVS Holdings, Inc.), Henderson, NV - 503A Facility

Guardian Pharmacy Services, Dallas, TX - 503A Facility - Out of business

FDA Press Release: Federal judge enters consent decree against Texas compounder, Guardian Pharmacy Services (03/12/2019)
483 Response Dated 06/08/2018 (PDF - 168KB)
Compounding Risk Alert: FDA’s Investigation into Guardian’s Compounded Triamcinolone-Moxifloxacin Drug Product (7/5/2018)
Amended 483 Issued 04/23/2018 (PDF - 3.1MB)
483 Issued 04/20/2018 (PDF - 2.7MB)
Warning Letter (11/03/2017)
Compounding Risk Alert: FDA Alerts Health Care Professionals of Adverse Events Associated with Guardian’s Compounded Triamcinolone and Moxifloxacin Product for Intravitreal Injection (7/28/2017)
Firm response to 483 dated 11/07/2016 (PDF - 3MB)
Corrected (No Redactions) 483 Issued 10/21/2016 (PDF - 361KB)

Hallandale Pharmacy, (see Pharmcore Inc.), Hallandale, FL - 503A Facility

Hallettsville Pharmacy, LLC, Hallettsville, TX - 503A Facility

FMD-145 Letter Issued 03/24/2021 (PDF - 185KB)
Referral Letter to the Texas State Board of Pharmacy Issued 03/24/2021 (PDF - 249KB)
Untitled Letter Issued 09/29/2020 (PDF - 182KB)
483 Issued 11/08/2018 (PDF - 468KB)

Hartley Medical Center Pharmacy, Inc., Long Beach, CA - 503A Facility

FMD-145 Letter Issued 07/06/2020
Warning Letter Close Out Issued 09/26/2017
Referral to the California State Board of Pharmacy Issued 09/26/2017 (PDF - 86KB)
483 Response dated (3/31/2017)
483 Issued 03/24/2017 (PDF - 203KB)
Warning Letter (04/21/2016)
Firm Press Release: Hartley Medical Issues Voluntary Recall of Prolotherapy with Phenol Due to Non-sterility Concerns (08/17/2015)
483 Issued 07/08/2015 (PDF - 548KB)

Hawaii Health Systems Corporation, (dba Kona Community Hospital Pharmacy), Kealakekua, HI - 503A Facility

Warning Letter Close Out Issued 06/27/2022
FMD-145 Letter Issued 06/27/2022
Warning Letter (02/01/2021)
483 Issued 12/13/2019 (PDF - 1.83MB)

Hazle Compounding, LLC, Hazelton, PA, 503A Facility

State Handoff Letter Issued 11/15/2022
FMD-145 Issued 11/15/2022

Healix Infusion Therapy, Inc., Sugar Land, TX - 503A Facility - De-registered as an Outsourcing Facility

State Referral Letter Issued 12/21/2017 (PDF - 75KB)
FMD-145 Letter Issued 12/21/2017 (PDF - 49KB)
483 Issued 09/14/2016 (PDF - 153KB)
483 Issued 05/16/2014 (PDF - 628KB)

Health and Wellness Compounding Pharmacy, (see Green Hills Health and Wellness Pharmacy, Inc.), Nashville, TN - 503A Facility

Health Dimensions, Inc., Farmington Hills, MI - 503A Facility

Referral Letter to the Michigan State Department of Licensing and Regulatory Affairs (LARA) Issued 05/21/2015 (PDF - 545KB)
483 Response Dated 08/27/2014 (PDF - 1.5MB)
483 Issued 08/08/2014 (PDF - 613KB)

Health Innovations Pharmacy, Inc., Southern Pines, NC - 503A Facility

Warning Letter Close Out Issued 04/21/2018
FMD-145 Letter Issued 04/21/2018 (PDF - 55KB)
Warning Letter (07/08/2016)
483 Issued 02/27/2015 (PDF - 805KB)

The Healthy Choice Apothecary (see Jacobs Pills Inc.), Elmsford, NY - 503A Facility

Healthy Choice Compounding LLC, Elmsford, NY 483 - 503A Facility

Untitled Letter Issued 07/15/2022 (PDF - 350 KB)
483 Issued 09/24/2020 (PDF - 254 KB)

Heartland Home Infusions, Inc. (dba HHI Infusion Services), Burr Ridge, IL - 503A Facility

FMD-145 Issued 02/22/2018 (PDF - 70 KB)
State Referral Letter Issued 02/22/2018 (PDF - 206 KB)
483 Issued 07/27/2017 (PDF - 391 KB)

Heartland I.V. Care, Saint Paul, MN - 503A Facility

State Referral Letter Issued 02/23/2018 (PDF - 81 KB)
FMD-145 Issued 02/23/2018 (PDF - 70 KB)
483 Issued 07/14/2017 (PDF - 162KB)

HHCS Pharmacy, Inc. (dba Freedom Pharmacy), Orlando, FL - 503A Facility

FMD-145 Letter Issued 01/23/2017
Referral Letter to the Florida State Board of Pharmacy Issued 01/23/2017 (PDF - 466KB)
Warning Letter Close Out Issued 01/20/2017
Warning Letter (05/14/2015)
483 Issued 07/28/2014 (PDF - 1.7MB)

Hieber's Pharmacy, Pittsburgh, PA - 503A Facility

Warning Letter Close Out Issued 05/01/2020
FMD-145 Letter Issued 05/01/2020 (PDF - 84KB)
483 Issued 07/17/2019 (PDF - 192KB)
Warning Letter (12/05/2017)
483 Issued 02/17/2017 (PDF - 1.2MB)
Warning Letter (09/29/2015)
483 Response Dated 10/07/2014 (PDF - 6.4MB)
483 Issued 09/18/2014 (PDF - 541KB)

Hiers Enterprises, LLC, (dba Northwest Compounding Pharmacy), Roseburg, OR - 503A Facility

FMD-145 Letter Issued 06/30/2023
Referral Letter to the Oregon Board of Pharmacy Issued 06/30/2023 (PDF - 250KB)
Untitled Letter Issued 09/22/2022 (PDF - 387KB)
483 Issued 11/10/2021 (PDF - 1.1MB)
483 Issued 11/14/2018 (PDF - 1.57MB)

Highland Pharmacy (see In Your Atmosphere Holdings, LLC), Santa Fe, NM - 503A Facility

Hikma Injectables USA Inc., Dayton, NJ - 503B Facility

FMD-145 Letter Issued 02/10/2023
483 Issued 06/08/2022 (PDF - 1.73MB)

Home Care Pharmacy of Palm Coast Inc., Palm Coast FL - 503A Facility

Untitled Letter Issued 05/04/2020 (PDF - 485KB)
483 Issued 04/25/2018 (PDF - 354KB)
Warning Letter (08/31/2017)
483 Issued 05/25/2016 (PDF - 860KB)

HomeChoice Partners, Inc., (dba Bioscrip Infusion Services), Augusta, GA - 503A Facility

FMD-145 Letter Issued 04/26/2022
State Referral Letter Issued 04/26/2022 (PDF - 162 KB)
Warning Letter Close Out Issued 04/14/2022
483 Issued 08/09/2021 (PDF - 905KB)
Warning Letter (04/09/2020)
483 Issued 08/17/2018 (PDF - 437KB)

Home Infusions Solutions, Inc., Horsham, PA - 503A Facility

Referral Letter to the Pennsylvania State Board of Pharmacy Issued 03/27/2014 (PDF - 144KB)
Facility Amended 483 Issued 05/21/2013 (PDF - 1.3MB)
483 Issued 05/21/2013 (PDF – 573KB)

Home Intensive Care Pharmacy, Inc., San Antonio, TX - 503A Facility

Referral Letter to the Texas State Board of Pharmacy Issued 05/05/2016 (PDF - 481KB)
483 Issued 05/05/2015 (PDF - 1.2MB)
Warning Letter Response Dated 02/09/2014
Warning Letter (01/22/2014)
483 Issued 03/01/2013 (PDF - 1.1MB)

HomeRx, LLC, (see WellRx, LLC), Wheaton, IL - 503A Facility

Hopewell Pharmacy and Compounding Center, (see Drugs Are Us, Inc.), Hopewell, NJ - 503A Facility

Hopkinton Drug, Inc., Hopkinton, MA - 503A Facility

FMD-145 Letter Issued 03/07/2022
Untitled Letter Issued 09/16/2021 (PDF - 273KB)
Amended 483 Issued 11/10/2020 (PDF - 622KB)

Horizon Pharmaceuticals, Inc., Riviera Beach, FL - 503A Facility

Warning Letter (12/23/2016)

Hospira Inc., A Pfizer Company, McPherson, KS - 503A Facility

483 Issued 01/17/2020 (PDF - 2.58MB)
483 Issued 10/27/2017 (PDF - 1.8MB)

HRI Pharmacy, (see National Prescription Services), Warrenville, IL - 503A Facility

Humco Holding Group, Inc., Texarkana, TX - 503A Facility

Warning Letter (01/26/2017)

Hunter Holmes McGuire Veterans Admin Medical Center, Richmond, VA - 503A Facility

483 Issue 07/19/2018 (PDF - 165KB)
483 Issued 10/25/2016 (PDF - 320KB)
483 Issued 03/11/2015 (PDF - 496KB)

HV Pharmacy Inc. (dba Hunt Valley PharmaLab), Cockeysville, MD - 503A Facility

FMD-145 Letter Issued 08/23/2019 (PDF - 323KB)
Referral Letter to the Maryland State Board of Pharmacy Issued 08/23/2019 (PDF - 87KB)
483 Issued 08/17/2018 (PDF - 290KB)

Hybrid Pharma LLC, Deerfield Beach, FL - 503B Facility

Warning Letter (06/07/2022)
483 Issued 09/03/2021 (PDF - 1.42MB)
Amended 483 Issued 06/24/2019 (PDF - 1.4MB)
Warning Letter (11/30/2018 )
483 Issued 07/28/2016 (PDF - 1.6MB)

Ideal Specialty Apothecary Inc., (dba Ideal Pharmacy), Union, NJ - 503A Facility

483 Issued 11/18/2021 (PDF - 1.48MB)
Warning Letter (06/17/2019)
483 Issued 08/31/2017 (PDF - 553KB)

ImprimisRx, LLC, Carlsbad CA - Corporate Headquarters

Warning Letter (06/30/2022)

ImprimisRx CA Inc. (dba ImprimisRx), Irvine CA - 503A Facility - Out of business

Warning Letter (03/26/2019)
Compounding Risk Alert: A Case of Hemorrhagic Occlusive Retinal Vasculitis (HORV) Following Intraocular Injections of a Compounded Triamcinolone, Moxifloxacin, and Vancomycin Formulation (10/3/2017)
Compounding Risk Alert: FDA Investigates Two Serious Adverse Events Associated with ImprimisRx’s Compounded Curcumin Emulsion Product for Injection (8/4/2017)
483 Issued 03/31/2017 (PDF - 558KB)
Warning Letter (03/20/2017)

Imprimis NJOF, LLC, Ledgewood, NJ - 503B Facility

483 Issued 01/29/2021 (PDF - 5.35MB)
Warning Letter (06/07/2019)
483 Issued 07/10/2017 (PDF - 1.6MB)

ImprimisRx NJ, Ledgewood, NJ - 503A Facility

483 Issued 08/05/2022 (PDF - 1.57MB)
483 Issued 04/09/2019 (PDF - 305KB)
Untitled Letter (09/25/2018)
483 Issued 07/10/2017 (PDF - 190KB)

ImprimisRx Pharmacy, LLC, Folcroft, PA - 503A Facility - Out of business

Warning Letter (08/03/2017)
483 Issued 08/01/2016 (PDF - 1.7 MB)

INCELL Corporation, LLC, San Antonio, TX - 503A Facility - De-registered as an Outsourcing Facility

Warning Letter Close Out Issued 05/24/2019
Warning Letter (10/28/2016)
483 Issued 09/01/2015 (PDF - 824KB)

Infupharma, LLC (dba President Pharmacy), Hollywood, FL - 503A Facility

Closeout Letter Issued 2/16/2016 (PDF - 404KB)
483 Issued 02/05/2015 (PDF - 685KB)
Warning Letter Close Out 06/26/2013
Warning Letter (07/30/2012)
483 Response Dated 10/10/2011 (PDF - 40KB)
483 Issued 09/27/2011 (PDF - 2.9MB)
Investigation Memo and Attachments, 08/16/2011 (PDF - 3.1MB)

InfuScience Inc., Eagan, MN - 503A Facility

FMD-145 Letter Issued 07/01/2019 (PDF - 101KB)
Referral Letter to the Minnesota State Board of Pharmacy Issued 07/01/2019 (PDF - 127KB)
483 Issued 04/25/2018 (PDF - 761KB)

InfuScience a subsidiary of Bioscrip, Mount Pleasant, SC - 503A Facility

Referral to the South Carolina State Board of Pharmacy Issued 09/13/2017 (PDF - 56KB)
483 Issued 05/15/2015 (PDF - 973KB)

InfuScience, Inc., (dba Bioscrip Infusion Services), Chantilly, VA - 503A Facility

483 Issued 10/08/2021 (PDF - 1.17MB)
Warning Letter (12/21/2020)
483 Issued 07/30/2019 (PDF - 1MB)

Infusion Options, Inc., Brooklyn, NY - 503A Facility - Out of business

Warning Letter (08/26/2021)
Amended 483 Issued 07/08/2019 (PDF - 2.16MB)
483 Issued 06/25/2019 (PDF - 261KB)
483 Issued 06/01/2017 (PDF - 1.3MB)
Warning Letter (03/21/2016)
483 Issued 04/23/2014 (PDF - 2.3MB)

Infusion Partners, LLC, Canfield, OH - 503A Facility

Warning Letter Close Out Issued 01/26/2022
FMD-145 Letter Issued 01/26/2022
Referral Letter to the Ohio Board of Pharmacy Issued 03/28/2019 (PDF - 75KB)
Warning Letter (03/20/2019)
483 Issued 01/26/2018 (PDF - 678KB)

Infusion Partners (subsidiary of BioScrip), Sharpsburg, PA - 503A Facility

483 Response Dated 01/09/2015 (PDF - 7.6MB)
Amended 483 Issued 12/10/2014 (PDF - 976KB)
483 Issued 12/05/2014

Infusion System of SW Florida Inc. (dba Myerlee Pharmacy), Fort Myers, FL - 503A Facility

FMD-145 Letter Issued 03/17/2023
Warning Letter Close Out Issued 03/17/2023
483 Issued 08/11/2022 (PDF - 447KB)
483 Issued 12/17/2019 (PDF - 690KB)
483 Issued 07/20/2017 (PDF - 1.36MB)
Warning Letter (02/03/2016)
483 Issued 12/22/2014 (PDF - 1.6MB)

Infusion Treatment Center, (dba ITC Compounding), Castle Rock, CO - 503A Facility

Referral Letter to the Colorado Board of Pharmacy Issued 11/23/2020 (PDF - 85 KB)
FMD-145 Letter Issued 12/01/2020 (PDF - 67KB)
Untitled Letter Issued 08/18/2020 (PDF - 158KB)
483 Issued 07/23/2019 (PDF - 1.6MB)

Innovative Compounding Pharmacy, Folsom, CA - 503A Facility

FMD-145 Letter Issued 06/07/2018 (PDF - 45KB)
State Handoff Letter Issued 06/07/2018 (PDF - 48KB)
Warning Letter Close Out Issued 06/07/2018
Warning Letter (06/20/2016)
483 Issued 04/17/2015 (PDF - 1MB)

Innovation Compounding, Inc. Kennesaw, GA - 503A Facility

Closeout Letter Issued 12/30/2016 (PDF - 200KB)

Innovative Intrathecal Solutions, Inc. (dba Innovative Compounding Pharmacy), Murrieta, CA - 503A Facility

Warning Letter Close Out Issued 04/04/2022
FMD-145 Letter Issued 04/04/2022
483 Issued 10/26/2021 (PDF - 248KB)
483 Issued 02/20/2020 (PDF - 983KB)
Warning Letter (09/19/2018)
483 Issued 12/18/2017 (PDF - 641KB)

Innovative Medicine LLC, Long Island City, NY - 503A Facility

Warning Letter (11/17/2020)

Innoveix Pharmaceuticals, Addison, TX - 503A Facility

Warning Letter (01/26/2022)
483 Issued 05/27/2021 (PDF - 981KB)
Firm Recall Announcement: Innoveix Pharmaceuticals, Inc. Issues Voluntary Recall of all Sterile Compounded Drug Products Due to a Lack of Sterility Assurance (10/10/2019)
483 Issued 09/12/2019 (PDF - 1.18MB)

Insight Pharmacy, Havertown, PA - 503A Facility

FMD-145 Letter Issued 10/03/2019 (PDF - 90KB)
Referral Letter to the Pennsylvania State Board of Pharmacy Issued 10/03/2019 (PDF - 90KB)

Intact Pharmaceuticals, LLC, New Milford, CT - 503B Facility - Out of business

483 Issued 10/12/2018 (PDF - 2.8MB)

IntegraDose Compounding Services, LLC, Minneapolis, MN - 503B Facility

483 Issued 08/02/2021 (PDF - 1.12MB)
Warning Letter (05/06/2020)
483 Issued 09/19/2018 (PDF - 1.3MB)

Integrated Health Concepts Inc. (dba Conversio Health), San Luis Obispo, CA - 503A Facility

FMD-145 Letter Issued 01/18/2022
Warning Letter Close Out Issued 01/18/2022
483 Issued 07/23/2021 (PDF - 454KB)
Warning Letter (09/10/2020)

Intermountain Medical Center, Murray, UT - 503A Facility

FMD-145 Letter Issued 10/25/2019 (PDF - 123KB)

Intrathecal Compounding Specialist, LLC, Scott, LA - 503A Facility

FMD-145 Letter Issued 01/19/2022
Warning Letter Close Out Issued 01/19/2022
483 Issued 08/19/2021 (PDF - 1.4MB)
Warning Letter (09/15/2020)
483 Issued 02/14/2019 (PDF - 417KB)
Firm response to 483 dated 12/08/2017 (PDF - 4.4MB)
Corrected 483 Issued 11/17/2017 (PDF - 499KB)

Inventive Infusion Solutions, LP, San Antonio, TX - 503A Facility

Untitled Letter Issued 07/15/2021 (PDF - 377KB)
483 Issued 08/31/2018 (PDF - 720KB)

In Your Atmosphere Holdings LLC (dba Highland Pharmacy) Santa Fe, NM - 503A Facility

Referral Letter to the New Mexico State Board of Pharmacy Issued 08/22/2017 (PDF - 78KB)
483 Issued 01/19/2017 (PDF - 1020KB)

Ionia Pharmacy, Tustin, CA - 503A Facility

Warning Letter (12/22/2015)
483 Issued 03/06/2015 (PDF - 2MB)

Irmat Pharmacy (see Park Irmat Corp.) New York, NY - 503A Facility

Isomeric Pharmacy Solutions, LLC, Salt Lake City, UT - 503A Facility - Out of business

FDA Press Release: Federal judge enters consent decree against outsourcing facility Isomeric Pharmacy Solutions (8/4/2017)
Firm Press Release: Isomeric Pharmacy Solutions Issues Voluntary Nationwide Recall of All Sterile Compounded Products (04/06/2017)
483 Issued 03/24/2017 (PDF - 3.3MB)
Warning Letter (12/12/2016)
483 Issued 06/29/2016 (PDF - 2.6MB)
483 Response Dated 09/17/2015 (PDF - 483KB)
483 Issued 08/28/2015 (PDF - 970KB)

Isorx, Corp., Richmond, CA - 503A Facility

FMD-145 Letter Issued 03/17/2022
483 Issued 09/18/2019 (PDF - 376KB)

IV Solutions of Lubbock (see Maxor National Pharmacy Services Corporation), Lubbock, TX - 503A Facility

I.V. Specialty, Ltd. Austin, TX - 503A Facility - Out of business

483 Issued 07/28/2017 (PDF - 594KB)
FDA Statement: FDA Alerts Health Care Professionals and Patients not to Use Human and Animal Sterile Drug Products Produced and Distributed by I.V. Specialty, Ltd., Austin, Texas (03/09/2016)
483 Issued 02/05/2016 (PDF - 1.5MB)
Warning Letter (04/21/2015)
483 Issued 07/22/2014 (PDF - 1019KB)

J & F International Inc. (dba Alexandria Medical Arts Pharmacy & Compounding Laboratory), Alexandria, VA - 503A Facility

Warning Letter Close Out Issued 12/13/2010
Warning Letter (04/09/2010)

Jack P. Herick Inc. (dba Glades Drugs), Pahokee, FL - 503A Facility

Referral Letter to the Florida Board of Pharmacy Issued 04/21/2017 (PDF - 711KB)
Warning Letter Close Out Issued 04/21/2017
Warning Letter (08/09/2016)
483 Issued 12/10/2015 (PDF - 606KB)
FDA Statement: FDA announces Glades Drugs’ nationwide voluntary recall of Compounded Multivitamins containing High Amounts of Vitamin D3 (Cholecalciferol) (11/25/2015)

Jacobs Pills Inc. (dba The Healthy Choice Apothecary), Elmsford, NY - 503A Facility

Warning Letter (05/31/2018)
483 Issued 02/28/2017 (PDF - 276KB)

Jajco Inc. (dba Anchor Drugs Pharmacy), South San Francisco, CA - 503A Facility

Referral Letter to the California State Board of Pharmacy Issued 12/06/2019 (PDF - 115KB)
FMD-145 Letter Issued 12/06/2019 (PDF - 100KB)
Warning Letter Close Out Issued 12/06/2019
483 Issued 10/29/2018 (PDF - 375 KB)
Warning Letter (08/22/2017)
483 Issued 06/03/2016 (PDF - 1.5MB)

JCB Laboratories, LLC, Wichita, KS - 503A Facility - Out of business

FMD-145 Letter Issued 09/22/2021
483 Issued 09/14/2018 (PDF - 213MB)
483 Issued 12/03/2015 (PDF - 1MB)
Warning Letter (07/07/2014)
Firm Press Release: JCB Laboratories Issues Voluntary Recall of Six Drug Product Lots Due to Concerns of Sterility Assurance at Testing Vendor (08/26/2013)
483 Issued 02/27/2013 (PDF - 1.9MB)

JD & SN Inc. (dba Moses Lake Professional Pharmacy), Moses Lake, WA - 503A Facility

483 Issued 04/04/2023 (PDF - 486 KB)
Warning Letter Close Out Issued 08/09/2018
FMD-145 Letter Issued 08/09/2018 (PDF - 46KB)
State Referral Letter Dated 08/09/2018 (PDF - 60KB)
483 Issued 07/12/2017 (PDF - 522KB)
Warning Letter (10/14/2016)
Firm Press Release: Moses Lake Professional Pharmacy Issues Voluntary Recall of Unexpired Sterile Human and Veterinary Compounded Drugs Due to Lack of Sterility Assurance (07/24/2015)
483 Issued 07/21/2015 (PDF - 2.6MB)

Jeffreys Drug Store, Canonsburg, PA - 503A Facility

Warning Letter CloseOut (08/16/2018)
FMD-145 Letter Issued 08/16/2018 (PDF - 62KB)
State Referral Letter Issued 08/16/2018 (PDF - 70KB)
483 Issued 08/04/2017 (PDF - 549KB)
Warning Letter (08/25/2016)
483 Issued 02/09/2016 (PDF - 579KB)

Joe Wise Pharmacy, Inc., (dba Wise Pharmacy), Littleton, CO - 503A Facility - Out of business

Warning Letter (04/15/2021)
483 Issued 06/21/2019 (PDF - 542KB)
483 Issued 05/23/2017 (PDF - 253KB)

John Hollis Pharmacy, (see John W. Hollis, Inc.), Nashville, TN - 503A Facility

John W. Hollis, Inc. (dba John Hollis Pharmacy), Nashville, TN - 503A Facility

FMD-145 Letter Issued 06/18/2016
Warning Letter Response Dated 09/18/2014
Warning Letter (09/04/2014)
483 Issued 03/21/2014 (PDF - 1.3MB)

John L. McClellan Memorial Veterans Hospital, Little Rock, AR - 503A Facility

Amended 483 Issued 01/23/2020 (PDF - 1.72MB)

John's Pharmacy, Inc., (dba The Sullivan Pharmacy), Sullivan, IL - 503A Facility

FMD-145 Letter Issued 05/26/2020 (PDF - 118KB)
Untitled Letter Issued 12/09/2019 (PDF - 648KB)
483 Issued 02/22/2019 (PDF - 384KB)

John’s Pharmacy LLLP, Cape Girardeau, MO - 503A Facility

Referral Letter to the Missouri State Board of Pharmacy Issued 01/10/2017 (PDF - 55KB)
FMD-145 Letter Issued 01/10/2017 (PDF - 215KB)

Johnson Compounding and Wellness, (see Merissa Corp.), Waltham, MA - 503A Facility

Johnson Memorial Cancer Center, Enfield, CT - 503A Facility

FMD-145 Letter Issued 11/28/2022
Warning Letter Close Out Issued 11/28/2022
483 Issued 10/21/2021 (PDF - 770KB)
483 Issued 10/19/2018 (PDF - 1.4MB)
Warning Letter (10/28/2015)
483 Issued 08/05/2014 (PDF - 916KB)

Jones Drug Company, Inc., (dba Reed's Compounding Pharmacy), Tucson, AZ - 503A Facility

FMD-145 Letter Issued 08/13/2020
Amended 483 Issued 09/29/2015 (PDF - 2.4MB)
483 Issued 09/29/2015 (PDF - 2.8MB)
Warning Letter (01/07/2008)

Jubilant DraxImage Radiopharmacies, Inc., (dba Triad Isotopes, Inc.), Kansas City, MO - 503A Facility

Warning Letter Close Out Issued 06/04/2020
Untitled Letter Issued 05/03/2018 (PDF - 87KB)
483 Issued 07/03/2017 (PDF - 217KB)
Referral Letter to the Missouri State Board of Pharmacy Issued 03/10/2016 (PDF - 225KB)
Warning Letter (03/10/2016)
Amended 483 Issued 01/09/2015
483 Issued 01/09/2015

Jubilant HollisterStier, LLC, Spokane, WA - 503A Facility - De-registered as an Outsourcing Facility

Jungle Jim's Pharmacy, Fairfield, OH - 503A Facility

Referral Letter to the Ohio State Board of Pharmacy Issued 08/11/2015 (PDF - 113KB)
483 Issued 01/26/2015 (PDF - 500KB)

J.W. Platt, RPh LLC. (dba The Wellness Pharmacy), Winchester, VA - 503A Facility

Kalman Health & Wellness, Inc. (dba Essential Wellness Pharma), Peoria, IL - 503A Facility

Warning Letter Close Out Issued 09/11/2019
Referral Letter to the Illinois State Board of Pharmacy Issued 09/11/2019 (PDF - 118KB)
FMD-145 Letter Issued 09/11/2019 (PDF - 84KB)
483 Issued 06/27/2018 (PDF - 201KB)
Warning Letter (07/22/2016)
483 issued 07/21/2015 (PDF 1.6MB)

Kelley-Ross Compounding Pharmacy, Seattle, WA - 503A Facility

Warning Letter Close Out Issued 04/08/2021
FMD-145 Letter Issued 04/08/2021
483 Issued 09/23/2020 (PDF - 754KB)
Warning Letter (07/30/2018)
Amended 483 Issued 08/02/2017 (PDF - 989KB)

Key Compounding Pharmacy (see Puget Sound Drug Corporation), Federal Way, WA - 503A Facility

Keystone Pharmacy, Grand Rapids, MI - 503A Facility

FMD-145 Issued 06/14/2018 (PDF - 171KB)
State Referral Letter Issued 06/14/2018 (PDF - 174KB)
483 Issued 11/03/2017 (PDF - 442KB)

Keystone Rx LLC, Bensalem, PA - 503A Facility

State Referral Letter Issued 03/25/2020 (PDF - 111KB)
FMD-145 Letter Issued 03/25/2020
483 Issued 07/12/2019 (PDF - 310KB)

Kings Park Slope, Inc., Brooklyn, NY - 503A Facility - De-registered as an Outsourcing Facility

Referral Letter to the New York State Board of Pharmacy Issued 11/15/2019 (PDF - 120KB)
FMD-145 Issued 11/15/2019 (PDF - 111KB)
Warning Letter Closeout (11/15/2019)
483 Issued 09/14/2018 (PDF - 593KB)
483 Issued 04/22/2016 (PDF - 1.4MB)
Warning Letter (03/27/2015)
483 Issued 03/14/2014 (PDF - 3.2MB)

Kohana Pharmacy and Center for Regenerative Medicine Inc., San Luis Obispo, CA - 503A Facility

FMD-145 Letter Issued 11/22/2019 (PDF - 69KB)
Referral Letter to the California State Board of Pharmacy Issued 11/22/2019 (PDF - 103KB)
483 Issued 04/17/2019 (PDF - 406KB)

Kohll's Compounding, Omaha, NE - 503A Facility

FMD-145 Letter Issued 07/11/2019 (PDF - 112KB)
Referral Letter to the Nebraska State Board of Pharmacy Issued 07/11/2019 (PDF - 264KB)

Kona Community Hospital Pharmacy, (see Hawaii Health Systems Corporation), Kealakekua, HI - 503A Facility

KRS Global Biotechnology, Inc. Boca Raton, FL - 503B Facility

Firm Recall Announcement: KRS Global Biotechnology, Inc. Issues Voluntary Nationwide Recall of All Human and Animal Sterile Drug Products Due to Lack of Assurance of Sterility (09/12/2019)
Amended 483 Issued 08/20/2019 (PDF - 2.51MB)
FMD-145 Letter Issued 06/13/2019
483 Issued 10/23/2017 (PDF - 705KB)
483 Issued 08/31/2016 (PDF - 2.2MB)
Warning Letter (07/06/2015)
483 Issued 03/17/2014 (PDF – 735KB)

Ladd Family Pharmacy LLC, Boise, ID - 503A Facility

Warning Letter Close Out Issued 04/09/2020
FMD-145 Letter Issued 04/09/2020
483 Issued 07/30/2019 (PDF - 321KB)
Warning Letter (09/26/2017)
483 Issued 09/23/2016 (PDF - 612KB)

Lato Drug Company, Inc. (dba Post Haste Pharmacy), Hollywood, FL - 503A Facility

FMD-145 Letter Issued 10/26/2017 (PDF - 67KB)
483 Issued 02/20/2015 (PDF - 712KB)

La Vita Compounding Pharmacy, LLC, San Diego, CA - 503A Facility

Warning Letter Close Out Issued 09/03/2020
FMD-145 Letter Issued 09/03/2020
483 Issued 03/11/2020 (PDF - 868KB)
Warning Letter (02/28/2019)
483 Issued 06/08/2018 (PDF - 870KB)

Lee and Company (dba Lee Pharmacy, Inc.), Fort Smith, AR - 503A Facility - Out of business

Warning Letter Response Dated 06/26/2014
Warning Letter (06/06/2014)
483 Issued 02/21/2013 (PDF - 2.6MB)

Lee Pharmacy, Inc. (see Lee and Company), Fort Smith, AR - 503A Facility

LeeSar, Inc., Fort Myers, FL - 503B Facility

Untitled Letter Issued 06/17/2022 (PDF - 7.62 MB)
483 Issued 10/29/2021 (PDF - 976KB)
Warning Letter (02/18/2020)
483 Issued 07/12/2017 (PDF - 991B)
483 Issued 08/08/2014 (PDF – 541KB)

Lee Silsby Compounding Pharmacy, (see Gipsco Investment Corp.), Cleveland Heights, OH - 503A Facility

Leiter's Cambrian Park Drugs, Inc., (dba Leiter's Compounding Pharmacy), 1700 Park Avenue, San Jose, CA - 503A Facility - Out of business

Warning Letter Response Dated 04/21/2015
Warning Letter (04/14/2015)
483 Response Dated 03/26/2014 (PDF - 3.6MB)
483 Issued 03/06/2014 (PDF - 1.3MB)
483 Response Dated 11/25/2013 (PDF - 5MB)
483 Issued 11/05/2013 (PDF - 3.8MB)
Firm Press Release: Leiter's Compounding Pharmacy Issues Voluntary Nationwide Recall of Three Product Lots Due to Lack of Assurance of Sterility Concerns Related to its Independent Testing Vendor (09/10/2013)

Leiter's Compounding, 17 Great Oaks Blvd., San Jose, CA - 503A Facility

FMD-145 Letter Issued 08/03/2021
483 Issued 12/19/2018 (PDF - 335KB)
FMD-145 Letter Issued 05/29/2018 (PDF - 41KB)
Warning Letter Close Out Issued 05/29/2018
483 Issued 06/15/2017 (PDF - 715KB)
Warning Letter (02/29/2016)
Amended 483 Issued 10/08/2014
483 Issued 10/07/2014

Leiter's Compounding Pharmacy, (see Leiter's Cambrian Park Drugs, Inc.), San Jose, CA - 503A Facility

Leiter's Health, (see Denver Solutions, LLC), Englewood, CO - 503A Facility

Liberty Drug and Surgical, Chatham, NJ - 503A Facility

Warning Letter Close Out Issued 02/25/2019
FMD-145 Letter Issued 02/25/2019 (PDF - 108KB)
Untitled Letter Issued 04/12/2018 (PDF - 79KB)
Warning Letter (03/14/2016)
Amended 483 Issued 05/26/2015 (PDF - 926KB)

Life Science Pharmacy, Inc., Harriman, NY - 503A Facility

Untitled Letter Issued 12/09/2020 (PDF - 211KB)
483 Issued 11/20/2019 (PDF - 663KB)

Lifetime Value Pharmacy III Inc., Santa Ana, CA - 503A Facility

FMD-145 Letter Issued 09/21/2021
Untitled Letter Issued 09/22/2020 (PDF - 130KB)
483 Issued 02/21/2019 (PDF - 1.9MB)

Lincare, Inc. (dba United Medical Home Infusion), Little Rock, AR - 503A Facility

FMD-145 Letter Issued 04/09/2018
Warning Letter Close Out Issued 03/05/2018
State Referral Letter Issued 03/05/2018 (PDF - 84KB)
483 Issued 08/22/2017 (PDF - 218KB)
Warning Letter (04/25/2016)
Amended 483 Issued 06/12/2015 (PDF - 1.5MB)
483 Issued 06/12/2015 (PDF - 1.3MB)

Lloyd Central Compounding Pharmacy, (see Portland Compounding Pharmacy, LLC), Portland, OR - 503A Facility

Loop Pharmacy & Home Medical, Saint Albans, WV - 503A Facility

483 Issued 09/25/2018 (PDF - 331KB)
Warning Letter (09/20/2017)
483 Issued 12/16/2016 (PDF - 1.1MB)

Louisville Pharmacy (see Spoonamore Drug Co., Inc.), Louisville, KY - 503A Facility

Lowlite Investments, Inc. (dba Olympia Pharmacy), Orlando, FL - 503A Facility

Warning Letter (02/18/2014)
Firm Press Release: Lowlite Investments, Inc. d/b/a Olympia Pharmacy Announces a Voluntary Multi-State Recall of All Sterile Compounded Products Compounded Between December 17, 2012, and March 27, 2013, Due to Concerns About Sterility Assurance (05/29/2013)
483 Issued 03/21/2013 (PDF - 717KB)

Lowlyn Pharmacies, Inc. (dba Red Cross Drug), Blanchard, OK - 503A Facility

Referral Letter to Oklahoma State Board of Pharmacy Issued 02/25/2014 (PDF - 2.4MB)
483 Issued 03/08/2013 (PDF - 732KB)

Lynnfield Drug, Inc. (dba Freedom Fertility Pharmacy), Byfield, MA - 503A Facility

FMD-145 Letter Issued 09/26/2018 (PDF - 68KB)
State Referral Letter Issued 09/24/2018 (PDF - 75KB)
483 Issued 02/27/2018 (PDF - 421KB)

Lynn Oaks Compounding Pharmacy, Thousand Oaks, CA - 503A Facility

State Referral Letter Issued 06/09/2023 (PDF - 317 KB)
FMD-145 Letter Issued 06/09/2023
Untitled Letter Issued 12/08/2022 (PDF - 401KB)
483 Issued 04/15/2022 (PDF - 1.19MB)

M Drug, LLC, (dba Northern Light Pharmacy), Bangor, ME - 503A Facility

State Referral Letter Issued 04/01/2020 (PDF - 180KB)
FMD-145 Letter Issued 04/01/2020 (PDF - 164KB)
Amended 483 Issued 08/20/2019 (PDF - 819KB)

Maag Prescription Center LLC, Pocatello, ID - 503A Facility

FMD-145 Letter Issued 09/23/2021
483 Issued 09/28/2018 (PDF - 745KB)

Madison Drugs (see Service First Pharmacies, Inc.), Huntsville, AL - 503A Facility

Magellan Rx Pharmacy LLC, Astoria, NY - 503A Facility

Warning Letter Close Out Issued 06/06/2019
FMD-145 Letter Issued 06/06/2019 (PDF - 92KB)
Referral Letter to the New York State Board of Pharmacy Issued 06/06/2019 (PDF - 95KB)
Warning Letter (09/11/2017)
483 Issued 12/22/2016 (PDF - 976KB)

Maimonides Medical Center-Pharmacy, Brooklyn, NY - 503A Facility

State Referral Letter Issued 07/20/2023 (PDF - 267KB)
483 Issued 03/09/2023 (PDF - 748KB)
483 Issued 07/29/2019 (PDF - 2.1MB)

Main Street Family Pharmacy, Newbern, TN - 503A Facility - Out of business

FDA Press Release: FDA resolves criminal and civil actions against Main Street Family Pharmacy (12/04/2014)
483 Issued 06/11/2013 (PDF - 873KB)
FDA Statement: Update on Main Street Family Pharmacy Products: Samples of injectable methylprednisolone acetate test positive for microbial contamination (06/06/2013; Updated 06/12/2014; Updated 06/13/2014)
Firm Press Release: Main Street Family Pharmacy, LLC Issues Voluntary Nationwide Recall of All Sterile Compounded Products (05/28/2013)
FDA Press Release: FDA alerts health care providers of adverse reactions associated with steroid injections from Main Street Family Pharmacy in Tennessee (05/24/2013)

Maitland Labs of Central Florida, Orlando, FL - 503A Facility - Out of business

Warning Letter (08/06/2021)
483 Issued 02/28/2020 (PDF - 1MB)
483 Issued 06/17/2019 (PDF - 1.06MB)

Malley's Compounding Pharmacy, (see Columbia River Pharmacy, LLC), Richland, WA - 503A Facility

Malanda, Inc., (dba Mandell's Clinical Pharmacy), Somerset, NJ - 503A Facility

Warning Letter Close Out Issued 11/09/2022
FMD-145 Letter Issued 11/09/2022
483 Issued 06/17/2022 (PDF - 662KB)
Warning Letter (06/09/2020)
483 Issued 07/25/2019 (PDF - 746KB)

Maplerose Enterprises, LLC (dba Pencol Pharmacy), Denver, CO - 503A Facility

FMD-145 Letter Issued 03/10/2022
Warning Letter Close Out Issued 03/10/2022
Untitled Letter Issued 08/18/2020 (PDF - 102KB)
Amended 483 Issued 02/26/2019 (PDF - 1.9MB)
Warning Letter (08/02/2017)
483 Response Dated 09/12/2016 (PDF - 537KB)
483 Issued (08/22/2016)

Mark Drugs Pharmacy, (see Snyder Mark Drugs Roselle, Inc.), Roselle, IL - 503A Facility

Marlborough Hospital, Marlborough, MA

Referral Letter to the Massachusetts Department of Public Health Issued 10/14/2015 (PDF - 38KB) - 503A Facility
483 Issued 09/17/2014

Martin Avenue Pharmacy, Inc., Naperville, IL - 503A Facility

Warning Letter Close Out Issued 10/16/2017
Warning Letter (03/18/2015)
Firm Press Release: Martin Avenue Pharmacy, Inc., Issues a Voluntary Multi-State Recall of All Compounded Sterile Preparations Due to a Lack of Assurance of Sterility (08/27/2014)
Amended 483 Issued 07/21/2014 (PDF - 1.8MB)

Maryland Specialty and Compounding, LLC dba Professional Arts Pharmacy, Baltimore, MD - 503A Facility - Ceased sterile compounding

Warning Letter Close Out Issued 5/29/2020 (PDF-186KB)
State Referral Letter Issued 5/29/2020 (PDF-203KB)
FMD-145 Letter Issued 5/29/2020

MasterPharm LLC. Richmond Hill, NY - 503A Facility - Out of business

Warning Letter (07/19/2021)
483 Issued 6/15/2020 (PDF-8MB)
Warning Letter Close Out Issued 07/07/2017
Referral to the New York State Education Department, Office of the Professions, Pharmacy Issued 07/07/2017 (PDF - 66 KB)
483 Issued 01/30/2017 (PDF - 220KB)
Warning Letter (01/08/2016)
483 Issued 05/06/2015 (PDF - 711 KB)

Matthew 7:25 Inc, (dba Thrive Pharmacy), Jacksonville, FL - 503A Facility

FMD-145 Letter Issued 01/27/2023
State Handoff Letter Issued 01/23/2023
Warning Letter Close Out Issued 01/23/2023
Warning Letter (07/22/2021)

Maxor National Pharmacy Services Corporation, (dba IV Solutions of Lubbock), Lubbock TX - 503A Facility

Referral Letter to the Texas Board of Pharmacy Issued 03/18/2014 (PDF - 604KB)
483 Response Dated 04/02/2013 (PDF - 976KB)
483 Issued 03/20/2013 (PDF - 3.7MB)
483 Issued 06/08/2007 (PDF - 427KB)

Mayo Clinic Pharmacy, Rochester, MN - 503A Facility

FMD-145 Letter Issued 04/10/2019 (PDF - 104KB)
Referral Letter to the Minnesota State Board of Pharmacy Issued 04/10/2019 (PDF - 123KB)
483 Issued 08/15/2018 (PDF - 2.41MB)

McAlister Drug Corporation, (dba Conrad-Marr Drug), Yukon, OK - 503A Facility

Referral Letter to the Oklahoma State Board of Pharmacy Issued 10/2/2020 (PDF - 199KB)
FMD-145 Letter Issued 10/01/2020
Untitled Letter Issued 08/21/2020 (PDF - 222KB)
483 Issued 10/03/2019 (PDF - 1.01MB)

McGuff Compounding Pharmacy Services, Inc., Santa Ana, CA - 503A Facility

FMD-145 Letter Issued 05/29/2020 (PDF - 60KB)
483 Issued 11/22/2019 (PDF - 978KB)
FMD-145 Letter Issued 08/17/2018 (PDF - 45KB)
State Handoff Letter Dated 08/17/2018 (PDF - 48KB)
Warning Letter Close Out Issued 08/17/2018
Warning Letter (11/13/2015)
483 Issued 12/31/2014

MD Custom Rx, (see Brookfield Prescription Center), Brookfield, WI - 503A Facility

Med 4 Home Inc., (dba Med 4 Home Pharmacy), Kansas City, MO - 503A Facility

Referral Letter to the Missouri Board of Pharmacy Issued 02/18/2015 (PDF - 306KB)

Medaus, Inc., Birmingham, AL - 503A Facility - Out of business

Warning Letter (03/08/2018)
FDA Press Release: FDA reminds health care professionals not to use drug products intended to be sterile from Medaus (05/05/2016)
FDA Requested Recall Letter Issued 05/03/2016 (PDF - 408KB)
FDA Statement: FDA alerts health care professionals and patients not to use sterile drug products from Medaus Pharmacy, Birmingham, Alabama (04/01/2016)
483 Issued 03/11/2016 (PDF - 872KB)
Warning Letter (01/15/2014)
Firm Press Release: Medaus Pharmacy Initiates a Nationwide Recall of Certain Pharmacy Products due to Questions Surrounding an Independent Third Party’s Sterility Testing (09/04/2013)
483 Issued 03/22/2013 (PDF - 712KB)

Medcraft LLC, Mounds, OK - 503A Facility - Out of business

FMD-145 Letter Issued 01/30/2019 (PDF - 77KB)
483 Issued 07/27/2018 (PDF - 251KB)

Medi-Fare Drug & Home Health Center, Inc., Blacksburg, SC - 503B Facility

Untitled Letter 03/18/2019 (PDF - 1.58MB)
Warning Letter Close Out Issued 09/27/2016
483 Issued 09/12/2014 (PDF - 371KB)
483 Issued 06/21/2013 (PDF - 2.4 MB)
Warning Letter (03/07/2013)
483 Issued 01/18/2013 (PDF - 3.5MB)

Medi-Home Infusion Pharmacy, Irmo, SC - 503A Facility

Referral Letter to the South Carolina State Board of Pharmacy Issued 05/21/2015 (PDF - 820KB)
483 Issued 09/17/2014 (PDF - 643KB)

Medical Center Pharmacy, Inc., Cleveland, TN - 503A Facility - De-registered as an Outsourcing Facility

483 Issued 04/09/2020 (PDF - 2.2MB)
Warning Letter (07/21/2017)
483 Issued 10/13/2015 (PDF - 1.2MB)

Medicine Store Pharmacy, Inc., (dba RXPress Pharmacy), Fort Worth, TX - 503A Facility

Referral to the Texas State Board of Pharmacy Issued 07/28/2017 (PDF - 55KB)

MedisourceRx, Los Alamitos, CA - 503B Facility

FMD-145 Letter Issued 04/14/2023
FMD-145 Letter Issued 06/28/2021
483 Issued 10/22/2020 (PDF - 1.15MB)
Amended 483 Issued 09/27/2018 (PDF - 1.9MB)
483 Issued 09/27/2018 (PDF - 2MB)

Medistat RX, LLC, (see Newman Inc.), Foley, AL - 503A Facility - Out of business

Meditech Laboratories, Inc., Las Vegas, NV - 503A Facility

State Referral Letter to the Nevada State Board of Pharmacy issued 12/06/2017 (PDF - 51KB)
FMD-145 Letter Issued 12/06/2017
Warning Letter Close Out Issued 12/06/2017
483 Issued 05/11/2017 (PDF - 58KB)
Warning Letter (10/19/2016)
483 Issued 03/18/2016 (PDF - 2MB)

Medlife Pharmacy and Compounding, Inc., Irvine, CA - 503A Facility

FMD-145 Letter Issued 11/29/2021
Warning Letter Close Out Issued 11/29/2021
Warning Letter (04/24/2020)
483 Issued 04/18/2018 (PDF - 845KB)

Medoz Pharmacy of Polk, Inc., Davenport, FL - 503A Facility - Ceased sterile compounding

FMD-145 Letter Issued 03/30/2022
Warning Letter Close Out Issued 03/30/2022
483 Issued 08/27/2021 (PDF - 244KB)
Warning Letter (09/25/2020)
483 Issued 08/09/2019 (PDF - 1.21MB)

MedPark Pharmacy, Annapolis, MD - 503A Facility

Warning Letter (03/05/2018)
483 Issued 3/10/2017 (PDF - 550KB)
483 Issued 05/23/2016 (PDF - 443KB)

MedPrep Consulting, Tinton Falls, NJ - 503A Facility - Out of business

DOJ Press Release: Senior Executives of Medical Drug Re-Packager Plead Guilty to Defrauding Healthcare Providers (July 14, 2017)
FDA Press Release: Federal Judge Enters Consent Decree with Med Prep Consulting (06/28/2013)
483 Issued 04/03/2013 (PDF - 6.9MB)
Firm Press Release: Medprep Consulting Inc. Announces Voluntary Nationwide Recall Of All Lots Of All Compounded Products Due To Potential Mold Contamination (03/20/2013)
FDA Press Release: FDA Alerts Health Care Providers of Recall of All Sterile Drug Products by Med Prep Consulting in New Jersey (03/18/2013)
Firm Press Release: MedPrep Consulting Inc. Announces Voluntary Nationwide Recall Of All Lots Of All Compounded Products Due To Potential Mold Contamination (03/17/2013)
Firm Press Release: MedPrep Consulting Inc. Announces Voluntary Nationwide Recall Of All Lots Of Magnesium Sulfate 2gm In Dextrose 5% In Water, 50ml For Injection Due To Mold Contamination (03/16/2013)
Warning Letter (07/09/2010)

Meds IV, (see Advanced Specialty Pharmacy), Bessemer, AL - 503A Facility

MedScript Compounding Pharmacy, (see D&D Pharma, LLC), Noblesville, IN - 503A Facility

Med Shop Total Care, Inc., Longview, TX - 503A Facility

483 Issued 06/08/2023 (PDF - 457 KB)
Warning Letter (03/18/2022)
483 Issued 07/27/2021 (PDF - 9.94KB)
483 Issued 11/01/2018 (PDF - 2.44MB)

Merissa Corp., (dba Johnson Compounding and Wellness), Waltham, MA - 503A Facility

Referral Letter to Massachusetts Board of Registration in Pharmacy Issued 01/20/2016 (PDF - 47KB)
483 Issued 05/28/2015 (PDF - 1MB)

Meta Pharmacy Services, (see Barclay Luke & Pillai Specialty Pharmacy PLLC), Las Vegas, NV - 503A Facility - De-registered as an Outsourcing Facility

Metro Drugs 3rd Avenue Corp, New York, NY - 503A Facility

FMD-145 Letter Issued 09/22/2021
Untitled Letter Issued 01/08/2021 (PDF - 658KB)
483 Issued 04/05/2019 (PDF - 3.92MB)

MFP Limited (dba Prescription Lab Compounding Pharmacy), Tucson, AZ - 503A Facility

Warning Letter Close Out Issued 06/27/2017
Referral Letter to the Arizona State Board of Pharmacy Issued 05/23/2017 (PDF - 59KB)
Warning Letter (11/16/2016)
483 Issued 09/10/2015 (PDF - 340KB)

Michigan Medicine, Ann Arbor, MI - 503A Facility

Warning Letter Close Out Issued 06/13/2019
FMD-145 Letter Issued 06/13/2019 (PDF - 88KB)
Referral Letter to the Michigan State Board of Pharmacy Issued 06/13/2019 (PDF - 123KB)
483 Issued 12/14/2018 (PDF - 3.78MB)

Miller’s Health Mart Pharmacy, (see D&S Enterprises, LLC), Vero Beach, FL - 503A Facility

Millers of Wyckoff, Inc., Wyckoff, NJ - 503A Facility

FMD-145 Letter Issued 06/17/2022
Untitled Letter Issued 12/01/2021 (PDF - 339KB)
483 Issued 10/09/2020 (PDF - 620KB)
Warning Letter CloseOut (02/26/2019)
FMD-145 Letter Issued 02/26/2019
State Referral Letter Issued 02/26/2019 (PDF - 218KB)
483 Issued 05/18/2017 (PDF - 413KB)
Warning Letter (06/07/2016)
483 Issued 07/16/2015 (PDF - 1.2MB)

Mills Pharmacy at McCalla, McCalla, AL - 503A Facility

FMD-145 Letter Issued 6/4/2020

Montana Compounding Pharmacy dba Montana Compounding Pharmacy and Wellness Center, Missoula, MT - 503A Facility

Warning Letter Close Out Issued 02/01/2022
FMD-145 Letter Issued 02/01/2022
483 Issued 09/22/2021(PDF -1.04MB)
Warning Letter (05/09/2018)
483 Issued 09/20/2016 (PDF - 518KB)
Warning Letter (12/11/2015)
483 Issued 05/08/2015 (PDF - 2.5MB)

Mooney's Pharmacy Inc., Johnson City, TN - 503A Facility

FMD-145 Letter Issued 05/09/2017 (PDF - 67KB)
Referral Letter to the Tennessee Board of Pharmacy Issued 04/05/2017 (PDF - 430KB)
483 Response Dated 09/10/2016 (PDF - 721KB)
483 Issued 09/02/2016 (PDF - 289KB)

Moore's Compounding Pharmacy, Corpus Christi, TX - 503A Facility

FMD-145 Issued 08/02/2018 (PDF - 45KB)
483 Issued 01/13/2017 (PDF - 298KB)

Moore's Pharmacy Inc., Sinton, TX - 503A Facility

Warning Letter (01/16/2018)
483 Issued 09/01/2016 (PDF - 1.7MB)

Morton Drug Company (dba Morton LTC), Neenah, WI - 503A Facility

Warning Letter Close Out Issued 06/13/2019
FMD-145 Letter Issued 06/13/2019 (PDF - 109KB)
Referral Letter to the Wisconsin State Board of Pharmacy Issued 06/13/2019 (PDF - 710KB)
483 Issued 08/31/2018 (PDF - 221KB)
Warning Letter (10/26/2016)
483 Issued 12/22/2015 (PDF - 754KB)

Moses Lake Professional Pharmacy, (see JD & SN Inc.), Moses Lake, WA - 503A Facility

MPRX Inc., dba Medical Park Pharmacy, Dallas, TX - 503A Facility - Out of business

483 Issued 11/22/2019 (PDF - 369KB)

MSLS LLC, (dba The Medicine Shoppe), Lees Summit, MO - 503A Facility

FMD-145 Letter Issued 04/27/2023
483 issued 9/28/2022 (PDF - 5.5MB)

Murray Avenue Apothecary, Pittsburgh, PA - 503A Facility - De-registered as an Outsourcing Facility

Warning Letter (01/07/2008)

Myerlee Pharmacy, (see Infusion System of SW Florida), Fort Myers, FL - 503A Facility

Mytilini Enterprises LLC, (see Bedford Pharmacy Inc.), Bedford, NH - 503A Facility

Nanobots Healthcare, LLC, (dba Assurance Infusion), Houston, TX - 503A Facility - Out of business

Warning Letter (06/12/2020)
483 Issued 12/03/2019 (PDF - 645KB)

National Central Pharmacy, (see Abilene Nuclear LLC), Abilene, TX - 503A Facility

National Prescription Services Inc., (dba HRI Pharmacy), Warrenville, IL - 503A Facility

FMD-145 Letter Issued 04/04/2017 (PDF - 213KB)
State Handoff Letter Issued 04/04/2017
483 Issued 11/24/2014

Nature's Pharmacy and Compounding Center, Asheville, NC - 503A Facility - Out of business

Warning Letter (05/09/2014)
483 Issued 11/22/2013 (PDF - 1MB)
Firm Press Release: Nature's Pharmacy and Compounding Center Issues Voluntary Recall of All Sterile Compounded Products Distributed Within North Carolina Due to Lack of Sterility Assurance (11/13/2013)

Nebraska Methodist Hospital, Omaha, NE - 503A Facility

Referral Letter to the Nebraska State Board of Pharmacy Issued 05/09/2016 (PDF - 336 KB)
483 Issued 12/18/2015 (PDF - 632 KB)
483 Issued 07/14/2014 (PDF - 772 KB)

Nemours Alfred I. duPont Hospital for Children, Wilmington, DE - 503A Facility

Referral Letter to the Delaware State Board of Pharmacy Issued 04/28/2017 (PDF - 910 KB)

Nephron Pharmaceuticals Corporation, dba Nephron Sterile Compounding Center, LLC, West Columbia, SC - 503B Facility

483 Issued 02/10/2023 (PDF - 5 MB)
Warning Letter Issued 10/21/2022
483 Issued 04/20/2022 (PDF - 3 MB)
FMD-145 Letter Issued 04/13/2022
483 Issued 11/15/2019 (PDF - 2 MB)
FMD-145 Letter Issued 05/17/2019
483 Issued 04/20/2018 (PDF - 321 KB)
FMD-145 Letter Issued 10/26/2017
483 Issued 04/21/2017 (PDF - 581 KB)

New England Compounding Center, Framingham, MA - 503A Facility

Unlicensed Pharmacy Technician Sentenced for Working at New England Compounding Center (7/17/2019)
Owner and Four Former Employees of New England Compounding Center Convicted Following Trial (12/13/2018)
Unlicensed Pharmacy Technician Pleads Guilty to Working at New England Compounding Center (8/17/2018)
Compounding Pharmacy Owner Sentenced to Five Years in Prison for $10.5 Million Health Care Fraud (3//27/2018)
DOJ Press Release: New England Compounding Center Pharmacist Sentenced for Role in Nationwide Fungal Meningitis Outbreak (January 31, 2018)
DOJ Press Release: Supervisory Pharmacist of New England Compounding Center Convicted of Racketeering Leading to Nationwide Fungal Meningitis Outbreak (October 25, 2017)
DOJ Press Release: Owner of New England Compounding Center Sentenced for Racketeering Leading to Nationwide Fungal Meningitis Outbreak (June 26, 2017)
DOJ Press Release: Owner of New England Compounding Center Convicted of Racketeering Leading to Nationwide Fungal Meningitis Outbreak (March 22, 2017)
DOJ Press Release: Majority Owner of NECC and Husband Plead Guilty to Illegal Cash Withdrawals Following Outbreak (July 29, 2016)
DOJ Press Release: $18 Million Seized from Owners of New England Compounding Center (1/6/2015)
DOJ Press Release: Luxury Car and Boat Seized From Former Head Pharmacist of New England Compounding Center (06/10/2015)
DOJ Press Release: 14 Indicted in Connection with New England Compounding Center and Nationwide Fungal Meningitis Outbreak (12/17/2014)
DOJ Press Release: New England Compounding Center Supervising Pharmacist Arrested at Logan International Airport (09/04/2014)
Multistate outbreak of fungal meningitis and other infections (12/12/2012)
Drug Safety Podcast: Investigation into New England Compounding Center (11/13/2012)
FDA Press release: FDA Reports Conditions Observed at New England Compounding Center Facility (10/26/2012)
483 Issued 10/26/2012 (PDF - 1.72MB)
Firm Press Release: New England Compounding Center Issues Voluntary Nationwide Recall of All Products (10/06/2012)
483 Issued 02/10/2003 (PDF - 457KB)

New England Home Therapies, Inc., Southborough, MA - 503A Facility

Referral to the Massachusetts State Board of Registration in Pharmacy Issued 09/26/2017 (PDF - 93KB)
483 Issued 01/27/2016 (PDF - 1.6MB)
483 Issued 10/08/2014 (PDF - 385KB)

New England Life Care, Inc., Portland, ME - 503A Facility

FMD-145 Letter Issued 10/08/2019
483 issued 03/02/2018 (PDF - 931KB)

New England Life Care, Inc., (dba Advanced Compounding Solutions), Woburn, MA - 503B Facility

Warning Letter Issued 05/16/2023
483 Issued 04/28/2022 (PDF - 3.08MB)
Untitled Letter Issued 8/21/2019 (PDF-182KB)
483 Response Dated 09/08/2017 (PDF - 234KB)
483 Issued 08/22/2017 (PDF - 1.19MB)

New England Life Care, Inc,, Woburn, MA - 503A Facility

FMD-145 Letter Issued 07/31/2019
483 Issued 02/08/2018 (PDF - 907KB)

New Era Pharmacy, LLC, (see Pharmacy Acquisition Co., LLC), Portland, OR - 503A Facility

Newman Inc., (dba Medistat RX, LLC), Foley, AL - 503A Facility

FDA Press Release: Federal Judge Enters Consent Decree Against Alabama Compounder Medistat (7/6/2017)
483 Issued 09/23/2015 (PDF - 1.7MB)
FDA Statement: FDA Announces Medistat RX's Nationwide Voluntary Recall of Sterile Drug Products (09/09/2015)
483 Issued 09/18/2014 (PDF - 798KB)
Warning Letter (06/24/2008)

New Vitalis Pharmacy, LLC, (dba New Vitalis Pharmacy), Louisville, KY - 503A Facility

Warning Letter (05/18/2022)
483 Issued 08/27/2021 (PDF - 894KB)
483 Issued 09/07/2018 (PDF - 531KB)

Nora Apothecary and Alternative Therapies, Inc., (dba Rx Compounding Inc.), Indianapolis, IN - 503A Facility

Amended 483 Issued 09/16/2016 (PDF - 652KB)
483 Response Dated 09/06/2016 (PDF - 1.2MB)
483 Issued 08/19/2016 (PDF - 626KB)
483 Issued 08/21/2014 (PDF - 422KB)
Warning Letter (02/14/2014)
Firm Press Release: Nora Apothecary & Alternative Therapies Announces a Voluntary Multi-State Recall of All Sterile Compounded Products Due to a Lack of Sterility Assurance (04/22/2013)
483 Issued 03/21/2013 (PDF - 309KB)

North American Custom Laboratories, LLC (dba FarmaKeio Superior Custom Compounding), Richardson, TX – 503A Facility

Warning Letter Issued 11/18/2022
483 Issued 03/10/2022 (PDF - 1.46MB)

Northern Light Pharmacy, (see M Drug, LLC), Bangor, ME - 503A Facility

Northern New England Compounding Pharmacy, LLC, (dba Eastern States Compounding Pharmacy), Littleton, NH - 503A Facility

Referral Letter to New Hampshire State Board of Pharmacy Issued 04/29/2015 (PDF - 117KB)
483 Response Dated 10/08/2014 (PDF - 678KB)
483 Issued 09/30/2014 (PDF - 455KB)

Northern VA Compounders PLLC, Sterling, VA - 503A Facility

483 Issued 12/09/2022 (PDF - 2MB)

North Laurel Discount Drug, Inc., (dba Quinn Pharmacy), Laurel, MS - 503A Facility

FMD-145 Letter Issued 10/15/2020 (PDF - 252KB)
Untitled Letter Issued 06/11/2020 (PDF - 467KB)
483 Issued 08/16/2018 (PDF - 236KB)

Northwest Compounding Pharmacy, (see Hiers Enterprises, LLC), Roseburg, OR - 503A Facility

Nubratori Inc. dba Nubratori Rx, Torrance, CA - 503B Facility

FMD-145 Letter Issued 05/06/2022
483 Issued 09/26/2019 (PDF - 637KB)
FMD-145 Letter Issued 05/15/2019 (PDF - 65KB)

Nutrishare Inc., Louisville, KY - 503A Facility

Referral Letter to the Kentucky State Board of Pharmacy Issued 03/04/2020 (PDF - 594 KB)
FMD-145 Letter Issued 03/04/2020 (PDF - 104KB)
483 Issued 07/26/2018 (PDF - 828KB)
Warning Letter (01/16/2018)
483 Issued 05/26/2017 (PDF - 75KB)

NuVision Pharmacy, (see Downing Labs, LLC), Dallas, TX - 503A Facility

Oakdell Pharmacy, Inc., San Antonio, TX - 503A Facility

State Referral Letter Issued 12/21/2017 (PDF - 80KB)
FMD-145 Letter Issued 12/21/2017 (PDF - 66KB)
483 Issued 03/29/2017 (PDF - 422KB)
Warning Letter Response Dated 06/18/2014
Warning Letter (05/27/2014)
483 Issued 03/01/2013 (PDF - 1.1MB)

O'Brien Pharmacy, Mission, KS - 503A Facility

FMD-145 Letter Issued 12/08/2021
Referral to the Kansas State Board of Pharmacy Issued 06/28/2017 (PDF - 100KB)

Olympia Pharmacy, (see Lowlite Investments, Inc.), Orlando, FL - 503A Facility

Olympia Pharmacy, (see OPS International, Inc.), Orlando, FL - 503B Facility

OncoMed (Onco 360), (see Sina LLC), Great Neck, NY - 503A Facility

One Way Drug, LLC, (dba Partell Specialty Pharmacy), Las Vegas, NV - 503A Facility

FMD-145 Letter Issued 6/16/2020 (PDF-61KB)
483 Issued 11/25/2019 (PDF - 351KB)
Warning Letter (03/13/2019)
483 Issued 03/08/2018 (PDF - 1.4MB)
483 Issued 07/19/2017 (PDF - 427KB)
Warning Letter (07/22/2015)
483 Issued 05/30/2014 (PDF - 1.3MB)

OPS International, Inc., (dba Olympia Pharmacy), Orlando, FL - 503B Facility

483 Issued 03/02/2022 (PDF - 4.08MB)
483 Issued 04/13/2018 (PDF - 1.6MB)
Warning Letter (02/04/2016)
483 Issued 12/04/2014 (PDF - 1.3MB)

Option Care, Wood Dale, IL - 503A Facility

FMD-145 Letter Issued 07/01/2020 (PDF - 121KB)
FMD-145 Letter Issued 07/01/2020 (PDF - 96KB)
Referral Letter to the Illinois State Board of Pharmacy Issued 07/01/2020 (PDF - 110KB)
483 Issued 02/08/2018 (PDF - 534KB)
Warning Letter (09/28/2017)
483 Issued 09/21/2016 (PDF - 432KB)

Option Care, Houston, TX - 503A Facility

FMD-145 Letter Issued 04/26/2018 (PDF - 54KB)
State Referral Letter Issued 04/26/2018 (PDF - 62KB)
483 Issued 08/02/2017 (PDF - 193KB)

Option Care Enterprises, Inc., (dba Option Care), Little Rock, AR - 503A Facility

State Referral Letter Issued 12/20/2019 (PDF - 82KB)
FMD-145 Letter Issued 12/20/2019 (PDF - 57KB)
483 Issued 03/12/2019 (PDF - 354KB)

Option Care Enterprises, Columbia, MD - 503A Facility

FMD-145 Letter Issued 4/23/2020 (PDF-232KB)
State Referral Letter Issued 4/23/2020 (PDF-196KB)
Amended Warning Letter (07/20/2017)
483 Issued 06/28/2016 (PDF - 1.2MB)

Option Care Enterprises Inc. Everett WA - 503A Facility

483 Issued 05/19/2017 (PDF - 100 KB)
Warning Letter (09/07/2016)
483 Issued 02/25/2016 (PDF - 2 MB)

Option Care, Inc., San Antonio, TX - 503A Facility

FMD-145 issued 04/12/2018 (PDF - 79 KB)
State Referral Letter Issued 04/12/2018 (PDF - 65 KB)

Optum Compounding Services, LLC, Phoenix, AZ - 503A Facility - De-registered as an Outsourcing Facility - Ceased Compounding Operations

FMD-145 issued 04/11/2022
483 Issued 08/13/2021(PDF - 2 MB)

Optum Infusion Services 308, LLC, Chandler, AZ - 503A Facility

Warning Letter Issued 12/13/2022
483 issued 3/18/2022 (PDF - 1 MB)

Oregon Compounding Centers, Inc., (dba Creative Compounds), Wilsonville, OR - 503A Facility - Out of business

Warning Letter (01/27/2015)
Firm Press Release: Oregon Compounding Centers, Inc. Issues Voluntary Recall of Unexpired Sterile Products in Oregon and Washington Due to Lack of Sterility Assurance (10/09/2014)
483 Response Dated 10/01/2014 (PDF - 5MB)
Amended 483 Issued 09/12/2014 (PDF - 1.9MB)
483 Issued 08/28/2014 (PDF - 1.7MB)

Orsini Pharmaceutical Services, Inc., (dba Orsini Healthcare), Elk Grove Village, IL - 503A Facility

Referral Letter to the Illinois State Board of Pharmacy Issued 10/31/2019 (PDF - 101KB)
FMD-145 Letter Issued 10/29/2019 (PDF - 102KB)
483 Issued 07/25/2018 (PDF - 67KB)

OSRX, Inc., Missoula, MT - 503A Facility

483 Issued 09/23/2021 (PDF - 386KB)

OurPharma LLC, Fayetteville, AR - 503B Facility

FMD-145 Letter Issued 03/14/2022
483 Issued 09/30/2021 (PDF - 445KB)

Overton Brooks VA Medical Center, Shreveport, LA - 503A Facility

483 Issued 02/12/2020 (PDF - 4.42MB)
483 Issued 02/17/2017 (PDF - 1.8MB)

Owl Tri State Pharmacy, (see Chastains, Inc.), Clarkston, WA - 503A Facility

Pacific Healthcare, Inc., (see BBS Pharmacy), Bellflower, CA - 503A Facility

Pacifica Pharmacy, Torrance, CA - 503A Facility

FMD-145 Letter Issued 07/08/2020 (PDF - 114KB)
Referral Letter to the California State Board of Pharmacy Issued 07/08/2020 (PDF - 84KB)
483 Issued 09/09/2019 (PDF - 440KB)
Warning Letter Response Dated 02/21/2008
Warning Letter (01/07/2008)

Pacifico National Inc., (dba Amex Pharmacy), Melbourne, FL - 503A Facility - De-registered as an Outsourcing Facility

Referral Letter to Florida State Board of Pharmacy Issued 03/10/2021 (PDF - 235KB)
FMD-145 Letter Issued 05/28/2020 (PDF - 68KB)
Firm Press Release: Pacifico National, Inc. dba AmEx Pharmacy Issues Voluntary Nationwide Recall for all Lots of Bevacizumab (08/30/2019)
FDA Press Release: FDA Requests Recall of Sterile Compounded Drug Products Produced by Pacifico National Inc., dba AmEx Pharmacy, Reminds Patients and Health Care Professionals to Stop Using Due to Potential Risks (08/30/2019)
Recall Letter Issued 08/23/2019 (PDF - 720KB with Sample Letter Issued 08/02/2019 (PDF - 6.34KB)
FDA Statement: FDA Warns Patients and Health Care Professionals not to Use Sterile Products from Pacifico National Inc., dba AmEx Pharmacy (06/28/2019)
483 Issued 06/20/2019 (PDF - 3.11MB)
483 Issued 01/21/2016 (PDF - 3.2MB)

Palisades Compounding Pharmacy, Pacific Palisades, CA - 503A Facility

483 Issued 03/15/2023 (PDF - 484KB)

Pallimed Solutions, Inc., Woburn, MA- 503A Facility - Out of business

Warning Letter (02/19/2014)
Amended 483 and Cover Letter Issued 04/09/2013 and 483 Issued 03/29/2013 (PDF - 15.9MB)
Firm Press Release: Pallimed Solutions, Inc. Announces Voluntary Nationwide Recall of All Sterile Compounded Products Dispensed Since January 1, 2013 Due to Possible Filament Contamination (03/25/2013)

Palm Beach Compounding, (see DNA Pharmacy Services, Inc.), Jupiter, FL - 503A Facility

Panorama Compounding Pharmacy, Lake Balboa, CA - 503A Facility

Warning Letter (01/07/2008)

Paradigm Healthcare Solutions, LLC, (dba Athena Pharmacy), Mount Juliet, TN - 503A Facility

Referral Letter to the Tennessee State Board of Pharmacy Issued 09/13/2019 (PDF - 71KB)
FMD-145 Letter Issued 09/13/2019 (PDF - 61KB)

Park Compounding, (see South Coast Specialty Compounding, Inc.), Irvine, CA - 503A Facility

Park Compounding Pharmacy, (see Chen Shwezin, Inc.), Westlake Village, CA - 503A Facility

Park Infusioncare LP (dba Preferred Homecare), Dallas, TX - 503A Facility - Out of business

Warning Letter (03/01/2018)
483 Issued 07/11/2017 (PDF - 553 KB)

Park Infusioncare LP (dba Preferred Homecare), Houston, TX - 503A Facility - Out of business

483 Issued 02/17/2017 (PDF - 615 KB)

Park Irmat Corp. (dba Irmat Pharmacy), New York, NY - 503A Facility

Closeout Letter Issued 05/18/2016 (PDF - 120KB)

Partell Specialty Pharmacy, (see One Way Drug, LLC), Las Vegas NV - 503A Facility

Partners in Care Inc., Gainesville, GA - 503A Facility

State Referral Letter Issued 10/31/2017 (PDF - 79KB)
483 Issued 03/07/2017 (PDF - 209KB)
483 Issued 06/10/2016 (PDF - 819KB)

Pathway Pharmacy, (see Avenue Pharmacy, Inc.), Ocala, FL - 503A Facility

Pavilion Compounding Pharmacy, Atlanta, GA - 503A Facility

Untitled Letter Issued 11/06/2020 (PDF - 277KB)
483 Response Dated 02/27/2019 (PDF - 2.53MB)
483 Issued 02/08/2019 (PDF - 717KB)

PCP LV LLC, (dba Pinnacle Compounding Pharmacy), Las Vegas, NV - 503A Facility - Out of business

Warning Letter (05/23/2016)
483 Issued 7/31/2015 (PDF - 800KB)

Pencol Pharmacy, (see Maplerose Enterprises, LLC), Denver, CO - 503A Facility

Pensacola Apothecary Inc., (dba Everwell Specialty Pharmacy), Pensacola, FL - 503A Facility

FMD-145 Letter Issued 04/22/2019 (PDF - 61KB)
Referral Letter to the Florida State Board of Pharmacy Issued 04/22/2019 (PDF - 54KB)
Warning Letter CloseOut (04/22/2019)
Warning Letter 6/28/2017
483 Response Dated 09/19/2016 (PDF - 1.5MB)
483 Issued 08/31/2016 (PDF - 1.1MB)

Pentec Health, Inc., 9 Creek Parkway, Boothwyn, PA - 503A Facility - Out of business

FMD-145 Letter Issued 04/09/2020 (PDF - 74KB)
FMD-145 Letter Issued 08/31/2018 (PDF - 102KB)
483 Issued 02/23/2018 (PDF - 571KB)

Pentec Health, Inc., 4 Creek Parkway, Boothwyn, PA - 503A Facility

State Referral Letter Issued 03/12/2018 (PDF - 79KB)
FMD-145 Letter Issued 03/12/2018 (PDF - 88KB)
Referral Letter to the Pennsylvania State Board of Pharmacy Issued 05/05/2017 (PDF - 318KB)
FMD-145 Letter Issued 05/05/2017 (PDF - 618KB)
Warning Letter (03/07/2014)
Firm Press Release: Pentec Health Announces Limited Voluntary Recall of Certain Compounded Prescription Therapies for Renal Patients (05/15/2013)
483 Issued 04/01/2013 (PDF - 924KB)

People's Custom Rx and Clinical Care, LLC, Memphis, TN - 503A Facility

FMD-145 Letter Issued 03/10/2022
483 Issued 08/05/2021 (PDF - 1.05MB)
FMD-145 Letter Issued 05/20/2020 (PDF - 199KB)
483 Issued 07/24/2019 (PDF - 390KB)
483 Issued 07/19/2018 (PDF - 441KB)
483 Issued 07/02/2018 (PDF - 408KB)
Warning Letter (06/06/2016)
483 Response Dated 08/13/2015 (PDF - 440KB)
483 Issued 07/29/2015 (PDF - 942KB)

People's Pharmacy, Inc. #1, Austin, TX - 503A Facility

483 Issued 12/07/2017 (PDF - 306KB)

People's Pharmacy, Inc. #2, Austin, TX - 503A Facility

Referral Letter to the Texas State Board of Pharmacy Issued 03/12/2019 (PDF - 65KB)
FMD-145 Letter Issued 03/12/2019
483 Issued 12/07/2017 (PDF - 510KB)
483 Issued 07/28/2014 (PDF - 560KB)

Perry Drugs Inc., Overland Park, KS - 503A Facility

Referral Letter to the Kansas State Board of Pharmacy Issued 03/29/2017 (PDF - 200KB)
Closeout Letter Issued 11/18/2016 (PDF - 155KB)
Warning Letter (02/03/2015)
483 Issued 09/09/2014 (PDF – 821KB)

Pet Pharmacy NW (formerly Health Solutions Pharmacy Center, Inc.), Corvallis, OR - 503A Facility - Ceased human drug compounding

State Handoff Letter Issued 11/10/2022
FMD - 145 Issued 11/10/2022
Warning Letter (03/31/2020)
483 Issued 01/28/2019 (PDF - 1 MB)

Pharmaceutical Care Solutions dba Pharmacy Solutions, Ann Arbor, MI - 503A Facility

Warning Letter (08/02/2021)

Pharmaceutic Labs, LLC, Albany, NY - 503A Facility

Warning Letter (05/03/2017)
483 Issued 09/23/2015 (PDF - 516KB)

Pharmacy Acquisition Co., LLC, (dba NewEra Pharmacy, LLC), Portland, OR - 503A Facility

FMD-145 Letter Issued 04/30/2020 (PDF - 60KB)
483 Issued 11/27/2019 (PDF - 626KB)

Pharmacy Associates, Inc., Huntington, WV - 503A Facility

483 Issued 05/24/2017 (PDF - 7.1MB)

Pharmacy Compounding Specialties, Dallas, TX - 503A Facility

Warning Letter (01/07/2008)

Pharmacy Creations, Randolph, NJ - 503A Facility

483 Issued 09/30/2015 (PDF - 368KB)
Firm Press Release: Pharmacy Creations Issues Voluntary Recall of Four Product Lots With Limited Distribution in Florida, New Jersey, New York, and Puerto Rico Due to Potential Non-Sterility (09/04/2014)
Warning Letter (06/23/2014)
483 Response Dated 09/03/2013 (PDF - 39KB)
483 Issued 08/19/2013 (PDF - 1.3MB)

Pharmacy Doctors Enterprises (dba Zion Clinical Pharmacy), Hallandale Beach, FL - 503A Facility

Untitled Letter Issued 08/17/2018 (PDF - 85KB)
483 Issued 11/20/2017 (PDF - 445KB)

Pharmacy Innovations, (see Southern Tier Home Infusion, Inc.), Erie, PA - 503A Facility

Pharmacy Plus, Inc. (dba Vital Care Compounder LLC), Hattiesburg, MS - 503A Facility

Warning Letter (06/06/2023)
483 Issued 10/13/2022 (PDF - 1.39MB)
483 Issued 05/16/2019 (PDF - 786KB)
Warning Letter (08/09/2017)
483 Issued 07/07/2016 (PDF - 1.5MB)

Pharmacy Resources Incorporated, Denver, CO - 503A Facility

FMD-145 Letter Issued 03/25/2020 (PDF - 66KB)
483 Issued 01/29/2019 (PDF - 1.2MB)
Warning Letter (03/01/2018)
483 Issued 05/23/2017 (PDF - 1.3MB)

Pharmacy Specialists of Central FL Inc., (dba Pharmacy Specialists), Altamonte Springs, FL - 503A Facility

FMD-145 Issued 06/03/2018 (PDF - 47KB)
State Referral Letter Issued 06/03/2018 (PDF - 53KB)
483 Issued 06/08/2017 (PDF - 251KB)

Pharmagen Laboratories, Inc, Stamford, CT - 503A Facility - Out of business

Amended 483 Issued 08/26/2013 (PDF - 1.1MB)
483 Issued 08/23/2013 (PDF - 1.1MB)

Pharmagen Laboratories, Silver Spring, MD - 503A Facility - Out of business

Warning Letter (10/24/2014)

Pharmakon Compounding Pharmacy Inc., Noblesville, IN - 503A Facility

Warning Letter (09/07/2017)
483 Issued 05/06/2016 (PDF - 1.9MB)

Pharmakon Long Term Care Pharmacy Inc., Noblesville, IN - 503A Facility - Out of business

Referral Letter to the Indiana State Board of Pharmacy Issued 03/06/2017 (PDF - 473KB)
483 Issued 05/11/2016 (PDF - 1.4MB)

Pharmakon Pharmaceuticals, Inc., Noblesville, IN - 503A Facility - Out of business

DOJ Press Release: Pharmacy Owner and Director of Compliance Charged with Defrauding United States and Distributing Adulterated Drugs (June 22, 2017)
Firm Press Release: Pharmakon Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of All Sterile Compounded Products Due to FDA Concern of Lack of Sterility Assurance (04/19/2016)
FDA Statement: FDA Alerts Health Care Professionals not to Use Sterile Drug Products from Pharmakon Pharmaceuticals, Inc., Noblesville, Indiana (04/15/2016)
Amended 483 issued 03/21/2016 (PDF - 3.5MB)
483 issued 03/16/2016 (PDF - 3.4MB)
FDA Statement: FDA Announces Pharmakon Pharmaceuticals Voluntary Recall of Morphine Sulfate 0.5 mg/mL Preservative Free in 0.9% Sodium Chloride (02/16/2016)
Warning Letter (05/21/2015)
483 Issued 04/08/2014 (PDF – 350KB)
483 Issued 03/13/2014 (PDF – 1.9MB)

PharmaLogic CSP, Inc., Bridgeport, WV - 503A Facility - Out of business

Warning Letter (04/29/2016)
483 Issued 12/12/2014

Pharmaview, Inc., (dba Far Hills Pharmacy), Bedminster, NJ - 503A Facility

FMD-145 Letter Issued 07/16/2020 (PDF - 139KB)
483 Issued 11/14/2019 (PDF - 392KB)

Pharmcore Inc. (dba Hallandale Pharmacy), Hallandale, FL - 503A Facility

FMD-145 Letter Issued 05/03/2022
483 Issued 09/24/2021 (PDF - 420KB)
Warning Letter (03/11/2020)
483 Issued 07/13/2018 (PDF - 1.38MB)

Pharm D Solutions, LLC, Houston, TX - 503A Facility - Out of business

FDA Press Release: Federal court enters consent decree against Texas compounder, Pharm D Solutions, LLC to cease the manufacturing of drugs intended to be sterile due to insanitary conditions (05/22/2019)
FDA Statement: FDA Alerts Health Care Professionals and Patients not to Use Sterile Drug Products from Pharm D Solutions (11/19/2018)
Firm Press Release: Pharm D Solutions, LLC Issues Voluntary Nationwide Recall of all Sterile Compounded Drugs Due to A Potential Lack of Sterility Assurance (9/10/2018)
483 Issued 08/28/2018 (PDF - 4.5MB)
Warning Letter (12/08/2016)
483 Issued 06/05/2015 (PDF - 585KB)

PharMEDium Services, LLC, Lake Forest, IL - 503A Facility

FDA Press Release: Federal Judge Enters Consent Decree Against Compounder PharMedium Services for Violations at Multiple Facilities (5/22/2019)
483 Issued 04/11/2018 (PDF - 2MB)
Firm Press Release: PharMEDium Services Issues Voluntary Nationwide Recall of Specific Lots of Potassium Phosphate and Succinylcholine Chloride Due to a Lack of Sterility Assurance (06/26/2017)
Firm Press Release: PharMEDium Issues Voluntary Nationwide Recall Sterile Preparations Compounded With a Single Recalled Lot of Fresenius Kabi Sensorcaine-MPF (bupivacaine HCl) Due to the Presence of Glass Particulate Matter (05/05/2016)
483 Issued 01/04/2016 (PDF - 1.2MB)
Firm Press Release: Pharmedium Issues Voluntary Nationwide Recall of 4mg Norepinephrine Bitartrate (16mcg/mL) Added to 0.9% Sodium Chloride in 250mL Viaflex Bag and 8mg Norepinephrine Bitartrate (32mcg/mL) Added to 0.9% Sodium Chloride in 250mL Viaflex Bag for Discoloration (12/31/2015)
Warning Letter (07/18/14)
FDA letter to PharMEDium (02/05/13)

PharMEDium Services, LLC, Cleveland, MS - 503A Facility

483 Issued 01/05/2018 (PDF - 2.9MB)
483 Issued 07/16/2015 (PDF - 635KB)
Warning Letter (07/18/14)
483 Issued 02/22/2013 (PDF – 1.9MB)

PharMEDium Services LLC, Dayton, NJ - 503A Facility - De-registered as an Outsourcing Facility

483 Issued 12/13/2017 (PDF - 2.4MB)
483 Issued 05/26/2016 (PDF - 1.5MB)

PharMEDium Services LLC, Edison, NJ - 503A Facility - Out of business

483 Issued 07/13/2015 (PDF - 1.1MB)
Warning Letter (07/18/14)
483 Issued 02/28/2013 (PDF - 2MB)

PharMEDium Services LLC, Memphis, TN - 503A Facility - De-registered as an Outsourcing Facility

Firm Press Release: Pharmedium Services, LLC Expands Voluntary Nationwide Recall of Additional Lots of Compounded Sterile Products Within Expiry Due to Lack of Sterility Assurance (01/11/2018)
Firm Press Release: PharMEDium Services, LLC Issues Voluntary Nationwide Recall of Certain Lots of Compounded Sterile Products due to Lack of Sterility Assurance (12/27/2017)
483 Issued 12/15/2017 (PDF - 3.8MB)
483 Issued 07/10/2015 (PDF - 1.5MB)
Warning Letter (07/18/14)
483 Issued 03/22/2013 (PDF - 10.4MB)

PharMEDium Service, Inc., Sugar Land, TX - 503A Facility - De-registered as an Outsourcing Facility

483 Issued 12/22/2017 (PDF - 2MB)
Firm Press Release: PharMEDium Services, LLC Issues Voluntary Nationwide Recall of all unexpired lots of Oxytocin Compounded with Either Lactated Ringers or Lactated Ringers and Dextrose Due to Sub-Potency (09/01/2017)
483 Issued 09/24/2015 (PDF - 898KB)
Warning Letter (07/18/14)
483 Issued 02/27/2013 (PDF – 1.1MB)

PharMerica LLC, Indianapolis, IN - 503A Facility - De-registered as an Outsourcing Facility

FMD-145 issued 02/21/2018 (PDF - 89KB)
State Referral Letter issued 02/21/2018 (PDF - 83KB)
483 Issued 02/23/2017 (PDF - 723KB)

PharmScript LLC, Somerset, NJ - 503A Facility

Referral Letter to the New Jersey State Board of Pharmacy Issued 07/29/2019 (PDF - 116KB)
FMD-145 Letter Issued 07/29/2019 (PDF - 104KB)
483 Issued 08/07/2018 (PDF - 640KB)
Warning Letter (08/23/2017)
483 Issued 10/24/2016 (PDF - 625KB)

Physician Preferred Medical, LLC, (dba PPM Pharmacy), Oklahoma City, OK - 503A Facility

Referral to the Oklahoma State Board of Pharmacy Issued 07/28/2017 (PDF - 72KB)
Warning Letter (01/20/2016)
483 Issued 02/19/2015 (PDF - 1.6MB)

Piedmont Hospital, Inc., (dba Phcy-Corp), Atlanta, GA - 503A Facility

Referral Letter to the Georgia State Board of Pharmacy Issued 08/14/2020 (PDF - 316KB)
FMD-145 Letter Issued 08/14/2020 (PDF - 192KB)
483 Issued 02/18/2020 (PDF - 156KB)

Pine Pharmaceuticals, Tonawanda, NY - 503B Facility

483 Issued 05/14/2021 (PDF - 1.47MB)
483 Issued 04/26/2018 (PDF - 783KB)
Warning Letter (11/07/2016)
483 Issued 10/09/2015 (PDF - 580KB)

Pine Pharmacy and Home Care Products Center, Inc., (dba Pine Pharmacy), Williamsville, NY - 503A Facility

FMD-145 Letter Issued 04/25/2019 (PDF - 104KB)
Referral Letter to New York State Board of Pharmacy Issued 11/07/2016 (PDF - 431KB)
483 Issued 04/18/2016 (PDF - 850KB)
Warning Letter (02/13/2015)
483 Issued 12/16/2013 (PDF – 5.3MB)
483 Issued 7/19/2013 (PDF – 1.4MB)

Pinnacle Compounding, Missoula, MT - 503A Facility

483 Issued 04/25/2019 (PDF - 278KB)

Pinnacle Compounding Pharmacy, (see PCP LV LLC), Las Vegas, NV - 503A Facility - Out of business

Plainsboro Pharmacy, Plainsboro, NJ - 503A Facility

Referral Letter to the New Jersey State Board of Pharmacy Issued 01/11/2017 (PDF - 62KB)
Warning Letter (08/01/2016)

Portage Pharmacy, Inc., Portage, MI - 503A Facility

Referral Letter to Michigan Board of Pharmacy Issued 02/25/2014 (PDF - 357KB)
483 Issued 03/06/2013 (PDF - 8.9MB)

Portland Compounding Pharmacy, LLC, (dba Lloyd Central Compounding Pharmacy), Portland, OR - 503A Facility

FMD-145 Letter Issued 04/07/2020 (PDF - 69KB)
483 Issued 11/26/2019 (PDF - 309KB)

Post Haste Pharmacy, (see Lato Drug Company), Hollywood, FL - 503A Facility

Potter’s House Apothecary, Inc., Peoria, AZ - 503A Facility

Referral Letter to the Arizona State Board of Pharmacy Issued 05/16/2022 (PDF - 307KB)
Untitled Letter Issued 09/15/2021 (PDF - 165KB)
Final Notice (PDF - 165 KB)
483 Issued 9/16/2020 (PDF - 5 MB)

Poulsbo Compounding Pharmacy, LLC, (dba Cascade Specialty Pharmacy), Poulsbo, WA - 503A Facility

Untitled Letter Issued 10/09/2020 (PDF - 584KB)
483 Issued 04/17/2019 (PDF - 710KB)

PPM Pharmacy, (see Physician Preferred Medical, LLC), Oklahoma City, OK - 503A Facility

PQ Pharmacy, LLC, Brooksville, FL - 503B Facility

Amended 483 Issued 10/27/2022 (PDF - 1.4MB)
483 Issued 10/27/2022 (PDF - 1.39MB)

PrecisionMed Pharmacy, Tampa, FL - 503A Facility

Untitled Letter Issued 6/10/2020 (PDF-255KB)

Precision Pharmacy Center, LLC, Brea, CA - 503A Facility - Out of business

Warning Letter (11/15/2016)
483 Issued 06/10/16 (PDF - 356KB)
483 Issued 04/01/2015 (PDF - 608KB)

Preckshot Professional Pharmacy, (see Central Illinois Compounding, Inc.), Peoria Heights, IL - 503A Facility

Preferred Homecare, (see Park Infusioncare LP), Houston, TX - 503A Facility - Out of business

Premier Pharmacy Labs, Inc., (dba Rx Nations), Weeki Wachee, FL - 503A Facility - Out of business

FDA Press Release: Federal Court Enters Consent Decree Against Florida Compounder, Prohibiting Manufacture and Distribution of Drugs Due to Insanitary Conditions (09/17/2021)
483 Issued 07/25/2019 (PDF - 3.63MB)
Firm Press Release: Premier Pharmacy Labs Issues Voluntary Nationwide Recall of all Unexpired Sterile Drug Product Lots Due to Lack of Sterility Assurance (06/18/2019)
Firm Press Release: Premier Pharmacy Labs Issues Voluntary Nationwide Recall of Specific Sterile Injectable Products Lots Due to a Potential Lack of Sterility Assurance (04/11/2018)
483 Issued 06/13/2016 (PDF - 1.4MB)
Warning Letter Response Dated 05/15/2015
Warning Letter (04/27/2015)
483 Issued 05/09/2014 (PDF – 2.5MB)

Premier Pharmacy Services, (see Good Health Inc.), Baldwin Park, CA - 503A Facility

Prescription Alternatives, Inc., Frisco, CO - 503A Facility

483 Issued 11/16/2018 (PDF - 3.8MB)

Prescription Dispensing Laboratories, Inc. dba PD Labs, Cedar Park, TX - 503A Facility

FMD-145 Letter Issued 02/18/2022
Warning Letter (07/30/2019)

Prescription Lab Compounding Pharmacy, (see MFP Limited), Tucson, AZ - 503A Facility

Prescription Labs, Inc. (dba Greenpark Compounding Pharmacy), Houston, TX - 503A Facility

FDA Press Release: FDA alerts patients and health care professionals not to use compounded products intended to be sterile from Prescription Labs Inc. dba Greenpark Compounding Pharmacy (09/17/2021)
483 Issued 08/12/2021 (PDF -6 6MB)
Warning Letter (10/26/2018)
483 Issued 10/27/2017 (PDF - 330KB)

President Pharmacy, (see Infupharma LLC), Hollywood, FL - 503A Facility

Prisma Health Outsourcing Facility, Simpsonville, SC

483 Issued 03/03/2023 (PDF - 656 KB)

Professional Arts Pharmacy, Baltimore, MD - 503A Facility

FMD-145 Letter Issued 03/11/2019 (PDF - 130KB)
Warning Letter Close Out (03/11/2019)
483 Issued 12/12/2017 (PDF - 565KB)
Warning Letter (04/03/2017)
483 Issued 03/23/2016 (PDF - 1.1MB)

Professional Arts Pharmacy, (see Compounding Pharmacies of Louisiana Inc.) Lafayette, LA - 503A Facility

Professional Compounding Pharmacy, (see Health Solutions Pharmacy Center, Inc.), Corvallis, OR - 503A Facility

Professional Partners Inc./ Westcliff Compounding Pharmacy, Newport Beach, CA - 503A Facility

Referral Letter to the California State Board of Pharmacy Issued 04/05/2017 (PDF - 357KB)
483 Issued 05/09/2016 (PDF - 715KB)

Professional Pharmacy Services, Inc. (dba Good Day Pharmacy), Longmont, CO - 503A Facility

FMD-145 Letter Issued 04/14/2020 (PDF - 65KB)
Referral Letter to the Colorado State Board of Pharmacy Issued 04/14/2020 (PDF - 83KB)
483 Issued 06/17/2019 (PDF - 554KB)
Untitled Letter Issued 01/02/2018 (PDF - 73KB)

Promise Pharmacy, LLC, Palm Harbor, FL - 503A Facility

Referral Letter to the Florida Board of Pharmacy Issued 07/27/2022 (PDF - 112KB)
FMD-145 Letter Issued 07/27/2022
483 Issued 09/23/2021 (PDF - 649KB)
FDA Statement: FDA Alerts Health Care Professionals and Patients not to use Drug Products Intended to be Sterile from Promise Pharmacy (12/7/2018)
Amended 483 Issued 11/12/2018 (PDF - 1.2MB)
483 Issued 10/25/2018 (PDF - 1.09MB)

Providence Health and Services Washington, (dba Providence Infusion Hospital Services), Tukwila, WA - 503B Facility

FMD-145 Letter Issued 08/16/2022
483 Issued 04/13/2022 (PDF - 433KB)
FMD-145 Letter Issued 09/10/2021
483 Issued 10/05/2020 (PDF - 1.46MB)

Puget Sound Drug Corporation, (dba Key Compounding Pharmacy), Federal Way, WA - 503A Facility

483 Issued 06/13/2019 (PDF - 1.27MB)
Warning Letter (04/04/2018)
483 Issued 03/08/2017 (PDF - 1.9MB)

Pure Pharmacy, (see Front Door Pharmacy), Houston, TX - 503A Facility

Purformance Wellness Pharmacy LLC, (dba Seven Cells), Stuart, FL

483 Issued 12/09/2022 (PDF - 510KB)

Qualgen LLC, Edmond, OK - 503B Facility

FDA Press Release: Federal Court Enters Consent Decree Against Oklahoma Drug Compounder (12/19/2022)
483 Issued 09/30/2022 (PDF - 1.69MB)
483 Issued 06/15/2021(PDF - 2.5MB)
483 Issued 09/13/2018 (PDF - 2.2MB)
483 Issued 05/10/2017 (PDF - 982KB)
Warning Letter (06/03/2016)
FDA Statement: FDA Alerts Health Care Professionals not to Use Sterile Drug Products from Qualgen (10/10/2015)
Amended 483 Issued 09/17/2015 (PDF - 2.5MB)

Queens Express Pharmacy, Jackson Heights, NY - 503A Facility - Out of business

483 Issued 07/11/2016 (PDF - 560KB)

Quinn Pharmacy, (see North Laurel Discount Drug, Inc.), Laurel, MS - 503A Facility

QuVa Pharma, Inc., Bloomsbury, NJ - 503B Facility

483 Issued 10/14/2022 (PDF - 2.54MB)
483 Issued 05/31/2019 (PDF - 1.69MB)
483 Issued 11/30/2017 (PDF - 406KB)

QuVa Pharma, Inc. Sugar Land, TX - 503B Facility

483 Issued 08/18/2022 (PDF - 638KB)
483 Issued 04/23/2019 (PDF - 693KB)
483 Issued 06/02/2017 (PDF - 313KB)
FMD-145 Letter Issued 03/24/2017 (PDF - 140KB)
Amended 483 Issued 02/08/2016 (PDF - 807KB)
483 Issued 02/05/2016 (PDF - 746KB)

QuVa Pharma Inc. Temple, TX - 503B Facility

FMD-145 Issued 01/3/2023
483 Issued 06/16/2022 (PDF - 743KB)
483 Issued 03/14/2019 (PDF - 1.14MB)
483 Issued 04/20/2018 (PDF - 676KB)
483 Issued 12/08/2016 (PDF - 279KB)

R & R Compounding Pharmacy, (dba Talon Compounding Pharmacy), San Antonio, TX - 503A Facility

RAM Pharma, Inc., Idaho Falls, ID - 503A Facility

483 Issued 08/01/2019 (PDF - 1 MB)
Warning Letter (10/27/2017)
483 Response Dated 03/22/2017 (PDF - 3 MB)
483 Issued 03/01/2017 (PDF - 6 MB)

Rancho Park Compounding Pharmacy, (see Sanders Pharmaceuticals, Inc.), Los Angeles, CA - 503A Facility

Randol Mill Pharmacy, Arlington, TX - 503A Facility

Warning Letter Close Out Issued 09/28/2022 (PDF - 174 KB)
FMD-145 Letter Issued 9/28/2022
Warning Letter (09/17/2020)
483 Issued 08/06/2019 (PDF - 874KB)

Ranier’s Compounding Laboratory, Jeannette, PA - 503A Facility

483 Issued 08/16/2021 (PDF - 1 MB)
FDA Press Release: Federal Court Enters Consent Decree Against Ranier's Rx Laboratory and Owner for Manufacturing Purportedly Sterile Drug Products in Unsanitary Conditions (02/06/2019)
FDA Statement: FDA Announces Ranier’s Rx Laboratory’s Voluntary Recall of All Sterile Compounded Drug (07/31/2018)
FDA Statement: FDA Alerts Health Care Professionals, Patients, Veterinarians and Animal Owners not to Use Sterile Drug Products from Ranier’s Compounding Laboratory (07/10/2018)
483 Issued 05/22/2018 (PDF - 1 MB)
Warning Letter (03/28/2017)
483 Issued 04/22/2016 (PDF - 1023KB)

RC Compounding Services, LLC, Poland, OH - 503A Facility - De-registered as an Outsourcing Facility

Referral Letter to the Ohio State Board of Pharmacy Issued 09/12/2019 (PDF - 159KB)
FMD-145 Letter Issued 09/12/2019 (PDF - 110KB)
483 Issued 02/16/2018 (PDF - 853KB)
483 Issued 09/14/2015 (PDF - 1002KB)
Warning Letter (07/14/2014)
483 Issued 02/07/2013 (PDF - 195KB)

RC Outsourcing LLC, Lowellville, OH - 503B Facility

483 Issued 09/23/2022 (PDF - 1.97MB)
FMD-145 Letter Issued 05/22/2020 (PDF - 105KB)
483 Issued 02/08/2019 (PDF - 5.39MB)
Warning Letter (11/28/2017)
483 Issued 03/31/2017 (PDF - 1.1MB)
Closeout Letter Issued 07/20/2016 (PDF - 27KB)
Amended 483 Issued 02/25/2016 (PDF - 1MB)
483 Issued 02/09/2016 (PDF - 869KB)

Red Cross Drug, (see Lowlyn Pharmacies, Inc.), Blanchard, OK - 503A Facility

Red Mountain Compounding Pharmacy, (see First Royal Care Co. LLC), Mesa, AZ - 503A Facility

Reed Pharmacy, Inc., Sterling, KS - 503A Facility

483 Issued 09/27/2018 (PDF - 323KB)

Reed's Compounding Pharmacy, (see Jones Drug Company, Inc.), Tucson, AZ - 503A Facility

Region Care, Inc., Great Neck, NY - 503A Facility - De-registered as an Outsourcing Facility

Referral to the New York State Board of Pharmacy Issued 06/15/2017 (PDF - 65KB)
483 Issued 06/10/2016 (PDF - 722KB)
Warning Letter (04/08/2015)
483 Issued 03/20/2014 (PDF – 922KB)

Reliable Drug Pharmacy, San Francisco, CA - 503A Facility

Warning Letter (03/09/2017)
Amended 483 Issued 04/20/2016 (PDF - 2MB)
FDA Statement: FDA Announces Voluntary Recall of All Unexpired Human and Animal Compounded Drug Products Produced by Reliable Drug Pharmacy, San Francisco (03/30/2016)
Firm Press Release: Reliable Drug Recall of all Compounded Medications Due to a Potential for Mislabeling and Lack of Quality Assurance (03/25/2016)
483 Issued 03/29/2016 (PDF - 2MB)

Reliant Compounded Solutions Monroe, LLC., Monroe, CT- 503A Facility

483 Issued 08/23/2023 (PDF - 543KB)

Reliant Pharmacy, (see Yeung Business Solutions), Southbury, CT - 503A Facility

Resource Optimization & Innovation LLC, Springfield MO - 503A Facility - De-registered as an Outsourcing Facility

Untitled Letter Issued 07/13/2018 (PDF - 348KB)
483 Issued 11/29/2016 (PDF - 851KB)

Revive RX LLC, dba Revive RX Pharmacy, Houston, TX - 503A Facility

483 Issued 05/04/2022 (PDF - 2.5MB)
483 Issued 08/06/2021 (PDF - 447KB)

Right Value Drug Store, Inc., (dba Carie Boyd’s Prescription Shop), Hurst, TX - 503B Facility

483 Issued 06/27/2022 (PDF - 2.4MB)
Warning Letter (09/20/2021)
483 Issued 11/12/2019 (PDF - 1.13MB)
Untitled Letter Issued 10/25/2019 (PDF - 347KB)
483 Issued 05/12/2017 (PDF - 207KB)
Warning Letter (07/25/2016)
483 Issued 12/12/2014

Riverpoint Pharmacy, (see First Pharma Associates LLC), Spokane, WA - 503A Facility

Rocky Mountain Pharmacy Inc, Bozeman MT - 503A Facility

FMD-145 Letter Issued 03/22/2022
Warning Letter (05/09/2019)
483 Issued 03/13/2018 (PDF - 227KB)

Roger Williams Medical Center, Providence, RI - 503A Facility

Untitled Letter Issued (3/18/2021) (PDF - 1 MB)
483 Issued 08/14/2019 (PDF - 1 MB)

Rushmore Compounding Pharmacy), (see CSRX Inc.), Rapid City, SD - 503A Facility

RX3 Pharmacy, (see RxSouth, LLC), Chester, VA - 503A Facility

Rx Compounding Inc., (see Nora Apothecary and Alternative Therapies, Inc.), Indianapolis, IN - 503A Facility

Rx Formulations, (dba Zions RX Formulations), Mesa, AZ - 503A Facility

Referral Letter to the Arizona Board of Pharmacy Issued 03/30/2015 (PDF - 725KB)
483 Issued 12/02/2014 (PDF - 526KB)
Warning Letter (08/15/2014)
FDA Statement: FDA Confirms Contamination in Rx Formulations’ Calcium Gluconate 10% Product (02/06/2014)
483 Issued 01/09/2014 (PDF - 1.04MB)
FDA Statement: FDA Announces Rx Formulation's Voluntary Recall of Sterile Drug Products (12/13/2013)

Rx Nations, (see Premier Pharmacy Labs, Inc.), Weeki Wachee, FL - 503A Facility

RXPress Pharmacy, (see Medicine Store Pharmacy, Inc.), Fort Worth, TX - 503A Facility

RXQ Compounding, LLC, Athens, OH - 503B Facility

Firm Press Release: RXQ Compounding, LLC Issues Voluntary Nationwide Recall of All Sterile Products within Expiry and Voluntarily Cessation of Production Due to the Lack of Sterility Process Assurance (06/18/2019)
483 Issued 06/06/2019 (PDF - 3MB)
483 Issued 08/08/2017 (PDF - 1.3MB)
Warning Letter (05/19/2016)
483 Issued 09/21/2015 (PDF - 1006KB)

RxSouth, LLC, (dba RX3 Pharmacy), Chester, VA - 503A Facility

FMD-145 Letter Issued 06/26/2019 (PDF - 88KB)
Referral Letter to the Virginia Board of Pharmacy Issued 10/27/2016 (PDF - 531KB)
Amended 483 Issued 04/18/2016 (PDF - 677KB)
483 Issued 04/18/2016 (PDF - 753KB)
Warning Letter Response Dated 11/12/2014
Warning Letter (10/23/2014)
483 Issued 02/21/2014 (PDF - 5MB)
Referral Letter to Virginia Board of Pharmacy Issued 08/13/2013 (PDF - 9.4MB)
483 Issued 12/14/2012 (PDF - 5.1MB)

Rxtra Solutions, (see Beacon Hill Medical Pharmacy), Southfield, MI - 503A Facility

Rx Unlimited Pharmacy, North Hills, CA - 503A Facility

483 Issued 10/21/2022 (PDF - 885KB)

Rye Beach Pharmacy, Inc., Rye, NY - 503A Facility

FMD-145 Letter Issued 12/28/2020 (PDF - 90KB)
Untitled Letter Issued 08/25/2020 (PDF - 151KB)

Safeway, Inc., San Jose, CA - 503A Facility

Referral Letter to the California State Board of Pharmacy Issued 09/29/2020 (PDF - 93KB)
Untitled Letter Issued 03/27/2019 (PDF - 424KB)
483 Issued 06/12/2017 (PDF - 227KB)

Saint John's Medical Plaza Pharmacy, Santa Monica, CA - 503A Facility

Warning Letter (01/07/2008)

Sagent Pharmaceuticals, Inc. (see SterRX)

Sanders Pharmaceuticals, Inc. (dba Rancho Park Compounding Pharmacy), Los Angeles, CA - 503A Facility

Referral Letter to the California State Board of Pharmacy Issued 12/27/2020 (PDF - 63 KB)
FMD-145 Letter Issued 11/27/2020 (PDF - 50KB)
483 Issued 05/07/2019 (PDF - 1.23MB)

San Diego Compounding Pharmacy, San Diego, CA - 503A Facility

FMD-145 Letter Issued 07/08/2019 (PDF - 211KB)
Referral Letter to the California State Board of Pharmacy Issued 07/08/2019 (PDF - 136KB)
Warning Letter (09/25/2017)
483 Issued 11/15/2016 (PDF - 275KB)

San Jose Compounding Pharmacy, (see White House Pharmacy, Inc.), San Jose, CA - 503A Facility

SaveWay Compounding Pharmacy, Inc., Newark, DE - 503A Facility

483 Issued 06/29/2017 (PDF - 180KB)
Warning Letter (10/04/2016)
483 Issued 10/02/2015 (PDF - 555KB)

SBH Medical LTD., Worthington, OH - 503A Facility

FMD-145 Letter Issued 06/16/2020 (PDF - 102KB)
483 Issued 09/30/2019 (PDF - 176KB)

SCA Pharmaceuticals, LLC, Little Rock, AR - 503B Facility

483 Issued 05/17/2023 (PDF - 1.05MB)
483 Issued 11/07/2019 (PDF - 724KB)
483 Issued 09/29/2017 (PDF - 1.1MB)
Warning Letter (06/25/2015)
483 Issued 04/01/2014 (PDF – 1.7MB)

SCA Pharmaceuticals, LLC., Windsor, CT - 503B Facility

483 Issued 11/19/2019 (PDF - 1.41MB)
Amended 483 issued 03/05/2018 (PDF - 855KB)
483 issued 03/05/2018 (PDF - 828KB)
Firm press release: SCA Pharmaceuticals Issues Voluntary Nationwide Recall of Specific Products Due to Potential Contamination (10/20/2017)

Sentara Enterprises, Chesapeake, VA - 503A Facility

483 Issued 12/16/2022 (PDF - 2.1MB)
483 Issued 08/06/2018 (PDF - 604KB)
Warning Letter (08/08/2016)
483 Response Dated 08/12/2015 (PDF - 3.5MB)
483 Issued 07/23/2015 (PDF - 1.1MB)

Service First Pharmacies, Inc. (dba Madison Drugs), Huntsville, AL - 503A Facility

Referral Letter to the Alabama State Board of Pharmacy Issued 08/14/17 (PDF - 60KB)
Warning Letter (04/27/2016)

Seven Cells, (see Purformance Wellness Pharmacy LLC), Stuart, FL

Sewaren Innovative Pharmaceutical Packaging dba SIPP, Avenel, NJ - 503A Facility - Out of business

483 Issued 06/28/2016 (PDF - 399KB)
Warning Letter (05/22/2017)

Sharp Drugs, Inc., West Hampton Beach, NY - 503A Facility Ceased Compounding Operations

State Handoff Letter Issued 10/20/2022
FMD-145 Letter Issued 10/20/2022
Warning Letter (9/10/2019)
483 Issued 07/13/2018 (PDF - 491 KB)

Shertech Pharmacy, LLC, Kernersville, NC - 503A Facility

483 Issued 07/18/2019 (PDF - 2.01MB)

Shertech Pharmacy, Easley, SC - 503A Facility

483 Issued 07/02/2019 (PDF - 1.16MB)

Shiraz Specialty Pharmacy Inc. (dba Axis Pharmacy Northwest), Mountlake Terrace, WA - 503A Facility

State Referral Letter to the Washington State Department of Health Issued 04/18/2018 (PDF - 82KB)
483 Issued 06/15/2017 (PDF - 717KB)

Sina LLC, (dba OncoMed (Onco 360)), Great Neck, NY - 503A Facility

Referral Letter to New York State Board of Pharmacy Issued 04/21/2015 (PDF - 79KB)
483 Issued 08/22/2014 (PDF – 936KB)

Sincerus Florida LLC, Pompano Beach FL - 503A Facility

FMD-145 Letter Issued 11/16/2020 (PDF - 209KB)
483 Issued 09/17/2018 (PDF - 766KB)
483 Issued 06/26/2017 (PDF - 447KB)
Warning Letter (12/21/2016)
483 Issued 07/15/2016 (PDF - 191KB)

Snyder Mark Drugs Roselle, Inc. (dba Mark Drugs Pharmacy), Roselle, IL - 503A Facility

483 Issued 09/27/2019 (PDF - 412KB)
Warning Letter (02/27/2018)
483 Issued 05/22/2017 (PDF - 2.1MB)

Solaris Pharmacy, Inc., Decatur, TX - 503A Facility

FMD-145 Letter Issued 07/17/2020 (PDF - 62KB)
483 Issued 02/26/2020 (PDF - 409KB)

Soleo Health, (see Biomed PA Inc.), Sharon Hill, PA - 503A Facility

South Berwick Pharmacy Seacoast Compounding, Inc., South Berwick, ME - 503A Facility

483 Issued 09/30/2022 (PDF - 735KB)

South Coast Specialty Compounding, Inc., (dba Park Compounding), Irvine, CA - 503A Facility

Amended 483 Issued 03/14/2016 (PDF - 1.7MB)
483 Issued 03/14/2016 (PDF - 1.9MB)
Referral Letter to the California State Board of Pharmacy Issued 06/23/2015 (PDF - 985KB)
483 Issued 07/02/2014 (PDF - 708KB)
Firm Press Release: Park Compounding: Sterile Medication Recall - Concerns of Sterility Assurance at Testing Vendor (09/10/2013)

Southern California Compounding Pharmacy, LLC, San Diego, CA - 503A Facility

FMD-145 Letter Issued 05/14/2020 (PDF - 60KB)
483 Issued 08/01/2019 (PDF - 529KB)

Southern Tier Home Infusion, Inc., (dba Pharmacy Innovations), Erie, PA - 503A Facility

483 Issued 11/30/2022 (PDF - 1.85MB)

Specialty Compounding, LLC, Cedar Park, TX - 503A Facility - Out of business

483 Issued 05/05/2015 (PDF - 418KB)
FDA Press Release: Federal Judge Enters Consent Decree Against Specialty Compounding LLC (03/11/2015)
FDA Statement: FDA Releases Laboratory Results of Specialty Compounding Recalled Products Confirming Contamination (11/15/2013)
Firm Press Release: Clarification to News Release Issued on August 9th Specialty Compounding, LLC Issues Nationwide Voluntary Recall of All Lots of Unexpired Sterile Products Due to Reports of Adverse Events (11/15/2013)
483 Issued 09/13/2013 (PDF - 9MB)
CDC Health Advisory: Nationwide Voluntary Recall of All Products for Sterile Use from Compounding Pharmacy Located in Cedar Park, Texas (08/14/2013)
FDA Press Release: FDA Announces Nationwide Voluntary Recall of All Products for Sterile Use from Specialty Compounding (08/11/2013)
FDA Statement: FDA Alerts Health Care Professionals about Sterile Products from Specialty Compounding (08/09/2013)
Firm Press Release: Specialty Compounding, LLC Issues Nationwide Voluntary Recall of All Lots of Unexpired Sterile Products Due to Reports of Adverse Events (08/09/2013)
483 Issued 03/22/13 (PDF – 744KB)

Specialty Medicine Compounding Pharmacy, P.C., South Lyon, MI - 503A Facility - Out of business

Warning Letter (08/31/2015)
483 Issued 11/05/2013 (PDF - 3.2MB)
FDA Press Release: FDA Announces Voluntary Recall of Certain Sterile Products from Specialty Medicine Compounding Pharmacy (10/22/2013)
Firm Press Release: Specialty Medicine Compounding Pharmacy Issues Voluntary Recall of Certain Unexpired Compounded Sterile Products (10/19/2013)

Spoonamore Drug Co., Inc., (dba Louisville Pharmacy), Louisville, KY - 503A Facility

State Referral Letter Issued 05/31/2018 (PDF - 76KB)
Warning Letter CloseOut (05/17/2018)
483 Issued 03/14/2017 (PDF - 333KB)
Warning Letter (12/18/2015)
483 Issued 02/03/2015 (PDF - 543KB)

SSM Health Care St. Louis, (dba SSM St. Clare Health Center), Fenton, MO - 503B Facility

483 Issued 09/28/2021 (PDF - 1.37MB)
483 Issued 08/28/2019 (PDF - 1.01MB)
483 Issued 11/16/2017 (PDF - 608KB)
Warning Letter (10/19/2015)
483 Issued 08/14/2014 (PDF – 711KB)

SSM St. Clare Health Center, (see SSM Health Care St. Louis), Fenton, MO - 503A Facility

Stanley Specialty Pharmacy Compounding and Wellness Center, Charlotte, NC - 503A Facility

483 Issued 10/01/2021 (PDF - 303KB)
Warning Letter (07/24/2018)
483 Issued 08/04/2017 (PDF - 191KB)
483 Issued 07/07/2016 (PDF - 373KB)

STAQ Pharma, Inc., Denver, CO - 503B Facility

FMD-145 Letter Issued 03/25/2022
483 Issued 09/29/2021 (PDF - 3.24MB)
483 Issued 09/03/2020 (PDF - 877KB)

SterRx (subsidiary of Sagent Pharmaceuticals), Plattsburgh, NY - 503B Facility

Warning Letter (07/27/2022)
483 Issued 11/04/2021 (PDF - 6.46MB)
FMD-145 Letter Issued 07/07/2020 (PDF - 212KB)
Untitled Letter Issued 10/17/2018 (PDF - 101KB)
483 Issued 03/17/2017 (PDF - 779KB)

Steven's Pharmacy, Costa Mesa, CA - 503A Facility

Warning Letter (11/12/2008)

Stewart Compounding Pharmacy, Fayetteville, NC - 503A Facility

483 Issued 10/10/2014 (PDF - 2 MB)
483 Issued 02/26/2014 (PDF - 1 MB)
Warning Letter (08/21/2013)
483 Issued 03/25/2013 (PDF - 7 MB)

Stokes Healthcare Inc., (dba Stokes Pharmacy), Mount Laurel, NJ - 503B Facility

Untitled Letter 4/27/2022 (PDF - 162 KB)
483 Issued 10/09/2020 (PDF - 603 KB)
483 Issued 06/19/2018 (PDF - 569 KB)
Referral Letter to the New Jersey State Board of Pharmacy Issued 01/03/2017 (PDF - 421 KB)
Closeout Letter Issued 8/31/2016 (PDF - 263 KB)
483 Response Dated 04/01/2016 (PDF - 2 MB)
483 Issued 02/12/2016 (PDF - 497KB)

Stonegate Pharmacy LP, Austin TX - 503A Facility

FMD-145 Letter Issued 09/21/2020 (PDF - 121KB)
Referral Letter to the Texas State Board of Pharmacy Issued 09/21/2020 (PDF - 210KB)
483 Issued 08/09/2019 (PDF - 1.48MB)
FMD-145 Letter Issued 04/24/2019 (PDF - 47KB)
Referral Letter to the Texas State Board of Pharmacy Issued 04/24/2019 (PDF - 69KB)
483 Issued 06/11/2018 (PDF - 502KB)
Warning Letter (11/10/2016)
Amended 483 Issued 03/02/2016 (PDF - 6MB)
483 Issued 03/02/2016 (PDF - 5.5MB)

Stone Oak Pharmacy LP, San Antonio, TX - 503A Facility

FMD-145 Letter Issued 03/14/2019 (PDF - 318KB)
Untitled Letter Issued 11/22/2017 (PDF - 1010KB)

Strohecker's Pharmacy, Portland, OR - 503A Facility - Out of business

Warning Letter (09/18/2017)
483 Issued 10/04/2016 (PDF - 1.1MB)

Summerton Drugs Compounding and Dispensary LLC dba Summerton Drugs, Summerton, SC - 503A Facility

Referral Letter to the South Carolina Department of Labor and Licensing- Board of Pharmacy Issued 02/15/2017 (PDF - 288KB)
483 Issued 10/17/2014 (PDF - 493KB)

Surgery Pharmacy Services, Inc., Chattanooga, TN - 503A Facility

483 Response Letter Issued 07/14/2023 (PDF - 179KB)
483 Issued 12/06/2019 (PDF - 755KB)
Warning Letter (10/09/2020)

Synergy Pharmacy Services, Palm Harbor, FL - 503A Facility - Out of business

Referral to the Florida State Board of Pharmacy Issued 07/28/2017 (PDF - 83KB)
Firm Press Release: Synergy Rx Pharmacy Issues Voluntary Nationwide Recall of All Lots of HCG (Human Chorionic Gonadotropin)Freeze Dried Vials Due to a Lack of Sterility Assurance (02/14/2017)
483 Issued 06/21/2016 (PDF - 1003KB)

Synthetopes, Inc., Conway, SC - 503A Facility

483 Issued 05/16/2019 (PDF - 1.40MB)

TMC Acquisitions, LLC dba Tailor Made Compounding, LLC, Nicholasville, KY - 503A Facility

483 Issued 03/22/2022 (PDF - 4.16MB)
Warning Letter (04/01/2020)
483 Issued 10/24/2018 (PDF - 1.7MB)
Amended 483 Issued 10/24/2018 (PDF - 2.5MB)

Tailstorm Health, Inc., Chandler, AZ - 503B Facility

Untitled Letter Issued 06/17/2022 (PDF - 404KB)
483 Issued 07/21/2021 (PDF - 1.24MB)

Talon Compounding Pharmacy, (see R & R Compounding Pharmacy), San Antonio, TX - 503A Facility

483 Issued 08/03/2018 (PDF - 880KB)
Warning Letter (10/03/2017)
Firm Press Release: Talon Compounding Pharmacy Issues Voluntary Nationwide Recall of HCG and Sermorelin Due to Lack of Sterility Assurance (07/22/2016)
483 Issued 06/29/2016 (PDF - 2.2MB)
483 Issued 06/24/2015 (PDF - 1.5MB)

Talon Pharmacy of Boerne, (see Vita Pharmacy, LLC), Boerne, TX - 503A Facility

Techni Med, Inc., (dba The Compounder), Aurora, IL - 503A Facility

FMD-145 Letter Issued 05/05/2020 (PDF - 101KB)
Referral Letter to the Illinois State Board of Pharmacy Issued 05/05/2020 (PDF - 106KB)
483 Issued 10/10/2019 (PDF - 553KB)
483 Issued 01/26/2018 (PDF - 1.7MB)
Warning Letter (07/29/2016)
483 Issued 07/09/2015 (PDF - 1001KB)

Texas Longhorn Rx, LLC

Warning Letter (8/30/2022)

The Apothecary Shoppe, LLC, Tulsa, OK - 503A Facility

Warning Letter (08/19/2016)
483 Issued 03/13/2015 (PDF - 1.3MB)

The Compounder, (see Techni Med, Inc.), Aurora, IL - 503A Facility

The Compounding Pharmacy, Hickory, NC - 503A Facility

483 Issued 09/29/2021 (PDF - 194KB)
Warning Letter (06/05/2020)

The Compounding Pharmacy of America, Knoxville, TN - 503A Facility

483 Issued 02/01/2018 (PDF - 222KB)
Warning Letter (06/09/2016)
483 Response Dated 06/26/2015 (PDF - 1.5MB)
483 Issued 05/21/2015 (PDF - 300KB)

The Compounding Pharmacy of Beverly Hills, Beverly Hills, CA - 503A Facility

FMD-145 Letter Issued 01/13/2021 (PDF - 66KB)
Untitled Letter Issued 09/17/2020 (PDF - 157KB)

The Compounding Shop, St. Petersburg, FL - 503A Facility - Out of business

Warning Letter (08/12/2014)
FDA Statement: FDA Alerts Patients and Health Care Providers Not to Use Budesonide Solution from The Compounding Shop (09/27/2013)
483 Issued 09/03/2013 (PDF - 97KB)
FDA Press Release: FDA Alerts Health Care Providers of Lack of Sterility Assurance of Drug Products from The Compounding Shop (05/08/2013)
Firm Press Release: In Cooperation with FDA, The Compounding Shop, LLC Declares a Voluntary Recall of All Lots of Sterile Compounded Products Due to a Lack of Sterility Assurance Distributed Within its Local Market Area (05/06/2013)
Amended 483 Issued 03/25/2013 (PDF - 10MB)
483 Issued 03/22/2013 (PDF - 1.3MB)

The Medicine Shoppe, (see Wood's Pharmacy, Inc.), Boones Mill, VA - 503A Facility

The Medicine Shoppe, (see MSLS LLC), Lees Summit, MO - 503A Facility

The Medicine Shoppe Pharmacy, Port Charlotte, FL - 503A Facility

Warning Letter (09/17/2021)
483 Issued 03/16/2020 (PDF - 1.07MB)

The Pet Apothecary LLC, Milwaukee, WI - 503A Facility

483 Issued 08/07/2018 (PDF - 1.14MB)

The Prescription Center, Fayetteville, NC - 503A Facility

FDA Press Release: FDA Alerts Health Care Professionals and Patients not to Use Products from the Prescription Center Pharmacy in Fayetteville, N.C. (04/02/2015)
NCBOP Press Release: North Carolina Board of Pharmacy Announces a Recall of All Lots of Non‐ Sterile and Sterile Products Compounded, Repackaged, and Distributed by Prescription Center Between September 10, 2014 and March 10, 2015 Due to Lack of Sterility, Potency, and Stability Assurance (04/01/2015)

The Ritedose Corporation, Columbia, SC - 503A Facility

483 Issued 03/18/2022 (PDF - 289KB)

The Sullivan Pharmacy, (see John's Pharmacy, Inc.), Sullivan, IL - 503A Facility

The Wellness Center Pharmacy, Inc., (dba Designer Drugs), Chattanooga, TN - 503A Facility

Referral Letter to the Tennessee Board of Pharmacy Issued 02/06/2019 (PDF - 54KB)
FMD-145 Letter Issued 02/06/2019 (PDF - 47KB)
483 Firm Response Dated 12/27/2017 (PDF - 848KB)
483 Issued 12/22/2017 (PDF - 323KB)
Warning Letter (08/05/2016)
483 Firm Response Dated 06/17/2015 (PDF - 6.7MB)
483 Issued 05/28/2015 (PDF - 1.2MB)

The Wellness Corner, Prairieville, LA - 503A Facility

FMD-145 Letter Issued 06/08/2018 (PDF - 47KB)
State Referral Letter Issued 06/08/2018 (PDF - 47KB)

The Wellness Pharmacy, LLC, (see J.W. Platt, RPh LLC.), Winchester, VA - 503A Facility

Untitled Letter Issued 01/24/2018 (PDF - 308KB)
483 Issued 05/16/2017 (PDF - 1.6 MB)
Warning Letter (03/23/2016)
483 Response Dated 03/16/2015 (PDF - 359KB)
483 Issued 03/12/2015 (PDF - 672KB)

Thrifty White Drug #762, Minneapolis, MN - 503A Facility

FMD-145 Letter Issued 05/27/2020 (PDF - 96KB)
483 Issued 09/21/2018 (PDF - 689KB)

Thrive Pharmacy, (see Matthew 7:25 Inc), Jacksonville, FL - 503A Facility

Tiberius, Inc., dba Custom Scripts Pharmacy, Wesley Chapel, FL - 503A Facility

FMD-145 Letter Issued 05/08/2018 (PDF - 63KB)
483 Issued 05/18/2017 (PDF - 467KB)

Total Pharmacy Services, Houma, LA - 503A Facility

FMD-145 Letter Issued 06/17/2019
483 Issued 09/30/2014 (PDF - 514KB)
Warning Letter (02/28/2014)
483 Issued 05/22/2013 (PDF - 311KB)

Total Vein Pharmacy, LLC, (dba Total Vein Pharmacy), Houston, TX - 503A Facility

483 Issued 05/09/2019 (PDF - 219KB)

Tower Pharmacy and Compounding, (see Botrosons Pharmaceutical Inc.), Mission Viejo, CA - 503A Facility

Town and Country Compounding and Consultation Services LLC, Ridgewood, NJ - 503A Facility

FMD-145 Letter Issued 08/11/2020 (PDF - 104KB)
483 Issued 12/11/2018 (PDF - 781KB)
Warning Letter (10/17/2017)
483 Issued 08/22/2016 (PDF - 1.1MB)

Town Total Compounding Center, Melville, NY - 503A Facility

Referral Letter to the New York State Board of Pharmacy Issued 01/09/2017 (PDF - 315KB)
FMD-145 Letter Issued 12/14/2016 (PDF - 225KB)
483 Issued 04/20/2016 (PDF - 1.1MB)

Transdermal Therapeutics, Inc., Birmingham, AL - 503A Facility

Closeout Letter Issued 05/27/2016 (PDF - 346KB)
483 Response Dated 10/14/2014 (PDF - 952KB)
483 Issued 06/27/2014 (PDF - 413KB)

Triad Isotopes, Inc., (see Jubilant Draximage Radiopharmacies, Inc.), Kansas City, MO - 503A Facility

Triad Rx, Inc., Daphne, AL - 503A Facility

483 Issued 12/08/2022 (PDF - 306KB)
Warning Letter (02/05/2019)
483 Issued 07/21/2017 (PDF - 516KB)

Triangle Compounding, Cary, NC - 503A Facility - De-registered as an Outsourcing Facility

FMD-145 Issued 6/17/2020 (PFD-91KB)
483 Issued 07/13/2017 (PDF - 2.2MB)
Warning Letter (11/02/2015)
483 Issued 01/16/2015 (PDF - 484KB)
483 Issued 09/22/2014 (PDF - 1MB)
Warning Letter (01/14/2014)
483 Issued 03/01/2013 (PDF - 880KB)

Tri-Coast Pharmacy Inc., Juno Beach, FL - 503A Facility - Out of business

Warning Letter (08/20/2018)
483 Issued 10/21/2016 (PDF - 945KB)
Firm Press Release: Tri-Coast Pharmacy Inc. Voluntarily Recalling All Sterile Products Prepared Between May 17, 2016 and November 17, 2016 Due to Concern Over Lack of Sterility Assurance (11/21/2016)

Tri-Med, Inc., (dba Advanced Care Infusion-Shelby), Shelby Township, MI - 503A Facility

State Referral Letter Issued 05/01/2018 (PDF - 77KB)
483 Issued 07/11/2017 (PDF - 615KB)
Warning Letter (12/18/2015)
483 Response Dated 03/12/2015 (PDF - 2.1MB)
483 Issued 02/23/2015 (PDF - 1.6MB)

Trinity Care Solutions (see Franck's Lab, Inc.), Ocala, FL - 503A Facility

Trone Health Services, Inc. (Medicap Pharmacy), Meridian, ID - 503A Facility

FMD-145 Letter Issued 07/19/2018 (PDF - 55KB)
State Referral Letter Issued 07/19/2018 (PDF - 61KB)
483 Issued 11/21/2017 (PDF - 210KB)
Warning Letter (03/22/2017)
483 Response Dated 08/03/2016 (PDF - 11.1MB)
483 Issued 07/15/2016 (PDF - 1.2MB)

TSDR Pharmacy, Inc. (dba brandMD Skin Care), Chatsworth, CA - 503A Facility

Warning Letter (11/09/2017)
483 Issued 03/28/2017 (PDF - 608KB)

UCSF Home Therapy Services, San Francisco, CA - 503A Facility

483 Issued 09/12/2014 (PDF – 893KB)

Unique Pharmaceutical, Ltd., Temple, TX - 503A Facility - Out of business

Closeout Letter Issued 12/11/2015 (PDF - 328KB)
483 Issued 01/23/2015 (PDF - 560KB)
FDA Press Release: FDA Announces Voluntary Nationwide Recall of All Non-Expired Sterile Drugs from Unique Pharmaceuticals (7/23/2014)
Firm Press Release: Unique Pharmaceuticals, Ltd. Announces a Voluntary Nationwide Recall of all Sterile Compounded Preparations Within Their Expiry Period Due to a Lack of Sterility Assurance (07/19/2014)
FDA Statement: FDA Alerts Health Care Professionals not to Use Sterile Drugs from Unique Pharmaceuticals (07/11/2014)
FDA Requested Recall Letter 07/11/2014 (PDF – 754KB)
483 Issued 06/20/2014 (PDF - 1MB)
Amended 483 Issued 04/04/2014 (PDF - 4.3MB)
483 Issued 04/02/2014 (PDF - 748KB)

United Pharmacy, LLC, West Palm Beach, FL - 503A Facility - Out of business

Warning Letter (02/11/2019)
Compounding Risk Alert: FDA investigates two adverse events associated with United Pharmacy’s compounded glutamine, arginine, and carnitine product for injection (11/8/2017)
483 Issued 08/18/2017 (PDF - 1MB)

University Compounding Pharmacy, (see Diversified Pharmacy Inc.), Troy, MI - 503A Facility

University of Michigan, Ann Arbor, MI - 503A Facility

Warning Letter (09/28/2017)
483 Issued 06/29/2016 (PDF - 1.3MB)

University of Washington Medical Center Inpatient Pharmacy, Seattle, WA - 503A Facility

Referral Letter to Washington State Board of Pharmacy Issued 08/01/2017 (PDF - 103KB)
483 Response Dated 08/24/2016 (PDF - 651KB)
483 Issued 08/04/2016 (PDF - 1.2MB)

University Pharmacy, Inc., Salt Lake City, UT - 503A Facility

Referral Letter to Utah State Board of Pharmacy Issued 02/20/2014 (PDF - 240KB)
483 Issued 02/26/2013 (PDF - 645KB)

University Rx Specialties Inc., San Diego, CA - 503A Facility

FMD-145 Letter Issued 10/8/21
FMD-145 Letter Issued 12/11/2018
483 Issued 10/27/2017 (PDF - 326KB)
Warning Letter (09/28/2016)
483 Issued 09/21/2015 (PDF - 1.5MB)

US Compounding Inc., Conway, AR - 503A Facility - Out of business

483 Issued 02/07/2019 (PDF - 2.11MB)
Warning Letter (10/10/2017)
483 Issued 07/15/2016 (PDF - 1.4MB)
Firm Press Release: US Compounding, Inc. Issues Voluntary Nationwide Recall of All Sterile Compounded Products (09/21/2015)
483 Issued 08/21/2015 (PDF - 2.3MB)
483 Issued 03/27/2014 (PDF – 1.1MB)

US Specialty Formulations LLC, Bethlehem, PA - 503B Facility

Warning Letter (07/26/2023)
483 Issued 04/26/2022 (PDF - 4.14MB)
483 Issued 07/23/2019 (PDF - 626KB)
483 Issued 08/29/2017 (PDF - 1MB)
Warning Letter (09/30/2016)
483 Issued 05/29/2015 (PDF - 1.7MB)

VA New Jersey Health Care System, East Orange, NJ - 503A Facility

483 Issued 02/27/2020 (PDF - 885KB)

Valgene Incorporated, (dba Cape Drugs), Annapolis, MD - 503A Facility

483 Issued 12/02/2021 (PDF - 766KB)
483 Issued 01/22/2018 (PDF - 635KB)
Warning Letter (08/12/2016)
483 Issued 10/07/2015 (PDF - 1.2MB)
FDA Statement: FDA alerts health care professionals not to use sterile drug products from Cape Apothecary, Inc., in Annapolis, MD (11/15/2015)

Valescent Compounding Inc. dba VPI Compounding, Centennial, CO - 503A Facility

FMD-145 Letter Issued 10/14/2021

Valor Compounding Pharmacy, Inc., dba Valor Compounding Pharmacy, Berkeley, CA - 503A Facility

483 Issued 09/15/2022 (PDF - 559KB)

Vann Healthcare Services, Inc., Glasgow, KY - 503A Facility

Vasco Pharmacy (see Vitalab Pharmacy, Incorporated), Phoenix, AZ - 503A Facility

Village Compounding Pharmacy, Houston, TX - 503A Facility

State Referral Letter Issued 02/02/2018 (PDF - 80KB)
FMD-145 Letter Issued 02/02/2018 (PDF - 49KB)
483 Issued 03/31/2017 (PDF - 266KB)
Warning Letter Response Dated02/19/2008
Warning Letter (01/07/2008)

Village Fertility Pharmacy, Inc., Waltham, MA - 503A Facility

Warning Letter (02/28/2014)
483 Issued 03/13/2013 (PDF - 393KB)

Village Pharmacy, Allentown, NJ - 503A Facility

FMD-145 Letter Issued 01/29/2021 (PDF - 88KB)
Warning Letter (10/30/2017)
483 Issued 06/22/2016 (PDF - 322KB)

Vita Pharmacy, LLC, (dba Talon Pharmacy of Boerne), Boerne, TX - 503A Facility

Warning Letter (08/29/2022)
483 Issued 11/02/2021 (PDF - 664KB)
FMD-145 Letter Issued 07/08/2020 (PDF - 208KB)
483 Issued 02/11/2020 (PDF - 640KB)

Vita Pharmacy, LLC, (dba Talon Compounding Pharmacy), San Antonio, TX - 503A Facility

FMD-145 Letter Issued 05/20/2022
483 Issued 10/06/2021 (PDF - 1.24MB)

Vitalab Pharmacy, Incorporated (dba Vasco Pharmacy), Phoenix, AZ - 503A Facility

Referral Letter to the Arizona State Board of Pharmacy dated 02/06/2020 (PDF - 79KB)
FMD-145 Issued 02/06/2020 (PDF - 68KB)
483 Issued 08/02/2019 (PDF - 169KB)
Warning Letter (01/10/2019)
483 Issued 04/04/2018 (PDF - 507KB)

Vital Care Compounder LLC, (see Pharmacy Plus, Inc.), Hattiesburg, MS - 503A Facility

Vital Care of Dickson, Dickson, TN - 503A Facility

Untitled Letter Issued 08/21/2020 (PDF - 429KB)
483 Issued 03/11/2020 (PDF - 405KB)

Vital Rx, Inc. dba Atlantic Pharmacy and Compounding, Pompano Beach, FL - 503A Facility - Out of business

Warning Letter (09/26/2018)
483 Issued 7/25/2017 (PDF - 945 KB)
Firm Press Release: Vital Rx, Inc. d/b/a Atlantic Pharmacy and Compounding Issues Voluntary Nationwide Recall of all Compounded Injectable Prescription Medications Due to Lack of Sterility Assurance (08/17/2017)
FDA Statement: FDA Alerts Health Care Professionals and Patients not to Use Sterile Drug Products from Vital Rx, dba Atlantic Pharmacy and Compounding (08/10/2017)

W & C (dba The Apothecary), Sartell, MN - 503A Facility

Referral Letter to the Minnesota State Board of Pharmacy Issued 10/22/2019 (PDF - 128KB)
FMD-145 Letter Issued 10/22/2019 (PDF - 103KB)
483 Issued 07/30/2018 (PDF - 397KB)
Warning Letter (07/20/2017)
483 Issued 06/17/2016 (PDF - 957KB)

Walfer Corporation dba Wallace Pharmacy (formerly The Medicine Shoppe Pharmacy), Port Charlotte, FL - 503A Facility

FMD-145 Letter Issued 9/20/2022

Walgreens Home Care, Inc. dba Walgreens Infusion Services, San Antonio, TX - 503A Facility

Warning Letter (10/19/2016)
483 Issued 08/06/2015 (PDF - 821KB)

Walgreens Infusion Services, Houston, TX - 503A Facility

Warning Letter (08/27/2015)
483 Issued 11/25/2014 (PDF - 1.1MB)

Walter's Pharmacy, Allentown, PA - 503A Facility

State Referral Letter Issued 05/09/2018 (PDF - 70KB)
Warning Letter (01/09/2017)
483 Issued 03/01/2016 (PDF - 903KB)

Weatherford Compounding Pharmacy, LLC, Weatherford, TX - 503A Facility

483 Issued 02/03/2012 (PDF - 460KB)

Wedgewood Connect, LLC, San Jose, CA - 503B Facility

FMD-145 Letter Issued 04/29/2022
483 Issued 12/03/2021 (PDF - 898KB)

Wedgewood Village Pharmacy, Inc., Swedesboro, NJ - 503A Facility - Ceased Compounding Human Drug Products

Warning Letter Close Out Issued 10/17/2022 (PDF - 206KB)
FMD-145 Letter Issued 08/02/2022
483 Issued 03/24/2022 (PDF - 2.44MB)
483 Response Dated 10/20/2015 (PDF - 1.1MB)
Amended 483 Issued 09/30/2015 (PDF - 1.1MB)
483 Issued 09/29/2015 (PDF - 1.3MB)
Warning Letter (02/21/2014)
483 Issued 02/11/2013 (PDF - 10.9MB)

Well Care Discount Pharmacy LLC, (dba Well Care Compounding Pharmacy), Las Vegas, NV - 503A Facility

Untitled Letter Issued 07/17/2019 (PDF - 86KB)
483 Issued 06/27/2018 (PDF - 467KB)
Warning Letter (03/29/2017)
Firm Press Release: Well Care Compounding Pharmacy Sterile Compounded Products: Recall - Lack Of Sterility Assurance (05/18/2016)
483 Issued 05/12/2016 (PDF - 1.6MB)

Wellcare Rx Investments, (dba Denson's Specialty Pharmacy), Wheaton, IL - 503A Facility

Warning Letter (09/30/2016)
Amended 483 Issued 01/06/2016 (PDF - 3.5MB)
483 Response Dated 12/07/2015 (PDF - 3.4MB)
483 Issued 11/19/2015 (PDF - 3.8MB)

Wellness Pharmacy, Inc., Birmingham, AL - 503A Facility

Referral Letter to the Alabama State Board of Pharmacy Issued 04/15/2015 (PDF - 581KB)
483 Response Dated 10/20/2014 (PDF – 2.2MB)
483 Issued 09/30/2014 (PDF – 251KB)
Firm Press Release: Wellness Pharmacy, Inc. Issues Voluntary Recall of Six Medications Due to Concerns of Sterility Assurance at Testing Vendor (08/26/2013)

WellRx, LLC (dba HomeRx, LLC), Wheaton, IL - 503A Facility

Wells Pharmacy Network, LLC, Ocala, FL - 503A Facility

FMD-145 Letter Issued 06/8/2020 (PDF-165KB)
483 Issued 06/22/2018 (PDF - 203KB)
Firm Press Release: Wells Pharmacy Network Issues Voluntary Nationwide Recall of Sterile Products due to Concern for Lack of Sterility Assurance (09/20/2016)
483 Issued 09/13/2016 (PDF - 812KB)
Warning Letter (11/10/2014)
483 Issued 06/19/2014 (PDF - 1MB)
483 Issued 03/07/2014 (PDF - 1.2MB)
483 Issued 07/26/2013 (PDF - 1.1MB)

Wells Pharmacy Network LLC, Dyersburg, TN - 503B Facility

Untitled Letter Issued 05/19/2022 (PDF - 315KB)
483 Issued 01/28/2021 (PDF - 4.5MB)
FMD-145 Letter Issued 08/06/2020 (PDF - 67KB)
FMD-145 Letter Issued 04/15/2020 (PDF - 119 KB)
483 Issued 04/27/2018 (PDF - 3.8MB)
483 Issued 10/20/2016 (PDF - 563KB)

Wells Pharma of Houston LLC, Houston, TX - 503B Facility

483 Issued 12/14/2022 (PDF - 611KB)
FMD-145 Letter Issued 01/10/2022
483 Issued 06/17/2021 (PDF - 240KB)

Westchester Compounding Pharmacy Inc., Eastchester, NY - 503A Facility

State Handoff Letter Issued 02/28/2023
FMD-145 Letter Issued 02/28/2023

West Coast Nuclear Pharmacy, LLC, Tampa, FL - 503A Facility

483 Issued 03/23/2018 (PDF - 673KB)

Western Drug Inc. dba Western Drug and General Store, Springerville, AZ - 503A Facility

Closeout Letter issued 6/12/2016 (PDF - 467KB)

Westlab Pharmacy, Inc., (dba Westlab Pharmacy), Gainesville, FL - 503A Facility

FMD-145 Letter Issued 1/10/2023
483 Issued 10/05/2021 (PDF - 908KB)
Warning Letter (06/26/2019)
483 Issued 08/15/2018 (PDF - 902KB)

White House Pharmacy, Inc., (dba San Jose Compounding Pharmacy), San Jose, CA - 503A Facility

FMD-145 Letter Issued 12/21/2021
483 Issued 09/14/2018 (PDF - 948KB)

Wickliffe Pharmaceutical, Inc., Lexington, KY - 503A Facility

483 Issued 04/07/2016 (PDF - 306KB)

Wiley Chemists, Inc., Santa Fe, NM - 503A Facility

483 Issued 10/02/2013 (PDF - 221KB)

William R. Grace M.D. P. C., New York, NY - 503A Facility

Referral to the New York City Department of Health and Mental Hygiene Issued 08/08/2017 (PDF - 71KB)
483 Issued 07/08/2016 (PDF - 485KB)

Wingate's Pharmacy and Compounding (see Anderson Holdings Inc.), Nashua, NH - 503A Facility

Wise Pharmacy, (see Joe Wise Pharmacy, Inc.), Littleton, CO - 503A Facility

Woodland Hills Compounding Pharmacy, (see Algunas, Inc.), Woodland Hills, CA - 503A Facility

Wood's Pharmacy, Inc., (dba The Medicine Shoppe), Boones Mill, VA - 503A Facility

483 Issued 01/15/2015 (PDF 2.4MB)

Yeung Business Solutions, LLC, (dba Reliant Pharmacy), Southbury, CT - 503A Facility

Referral Letter to the Connecticut Commission of Pharmacy Issued 03/25/2015 (PDF - 68KB)

Zion Clinical Pharmacy, (see Pharmacy Doctors Enterprises), Hallandale Beach, FL - 503A Facility

Zions RX Formulations Services, (see Rx Formulations), Mesa, AZ - 503A Facility

Contract Testing Laboratories

Analytical Research Laboratories, (see ARL Biopharma, Inc.), Oklahoma City, OK

ARL Biopharma, Inc., (dba Analytical Research Laboratories), Oklahoma City, OK

483 Issued 11/08/2012 (PDF - 382KB)

Boston Analytical, Inc., Salem, NH

483 Issued 11/09/2012 (PDF - 490KB)

Dyna Labs, LLC, St. Louis, MO

483 Issued 11/13/2012 (PDF - 1MB)

Eagle Analytical Services, Houston, TX

483 Response Dated 07/09/2013 (PDF - 2.8MB)
483 Issued 06/17/2013 (PDF - 984KB)

Front Range Laboratories, Inc., Loveland, CO

483 Issued 08/30/2013 (PDF - 1.6MB)
FDA Letter to Front Range Customers (PDF – 65KB) (08/23/2013)
FDA Statement: FDA Alerts Pharmacies to Concerns with Testing Conducted by Front Range Laboratories (08/21/2013)

Active Ingredient Suppliers

Darmerica LLC, Casselberry, FL

Firm Press Release: Darmerica LLC Issues Voluntary Nationwide Recall of Quinacrine Dihydrochloride Due to A Labeling Error (9/12/2019)

Medisca Inc., Saint-Laurent, Quebec, Canada, and Plattsburgh, NY

Warning Letter (11/25/2015)
Redacted 483 Issued 02/14/2014 (PDF - 175KB)
FDA Statement: FDA Lab Testing Finds N-acetyl-leucine in Samples of Recalled Medisca Product Labeled as L-citrulline (2/17/2015, 2/15/2014, and 2/14/2014)

Professional Compounding Centers of America, dba PCCA, Houston, TX

Warning Letter (01/27/2021)

Sichuan Friendly Pharmaceutical Co., Limited, China

FDA Statement: FDA Alerts Drug Makers of a Recall of Porcine Thyroid API from Sichuan Friendly Pharmaceutical Co., Limited, China (8/17/2018; updated 9/5/2018)

Taizhou Xinyou Pharmaceutical & Chemical Co., Limited, Taizhou City, Zhejiang Province, China

FDA Statement: FDA Warns of Potential Contamination of Baclofen Active Pharmaceutical Ingredient from Taizhou Xinyou Pharmaceutical & Chemical Co., Limited, China (12/09/2015)

Related Information

Compounding

Resources for You

See FDA's Enforcement Report to Search Recalls, Including Compounded Drug Products Inspections, Recalls, and Other Actions with Respect to Firms that Engage in Animal Drug Compounding