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  6. Warning Letters 2019
  1. Warning Letters and Notice of Violation Letters to Pharmaceutical Companies

Warning Letters 2019

These letters are supplied by the CDER Freedom of Electronic Information Office. This page only covers Office of Prescription Drug Promotion and CDER Headquarters Warning Letters. For District Office Warning Letters see the Main FDA FOI Warning Letters Page. Some of the letters have been redacted or edited to remove confidential information. Matters described in FDA warning letters may have been subject to subsequent interaction between FDA and the recipient of the letter that may have changed the regulatory status of the issues discussed in the letter.     

If you wish to obtain available additional information on the current status of an issue in a particular warning letter or notice of violation on this website, please contact the Agency or the recipient of the letter directly. Inquiries to FDA should be sent to: 

Food and Drug Administration
Freedom of Information Staff (HFI-35)
5600 Fishers Lane, Rockville, MD 20857

Instructions for how to submit an FOI request can be found on the FDA Freedom of Information Page.

Office of Prescription Drug Promotion

Company/Individual

Product/Issue

Issue Date

Alkermes, Inc.

NDA 021897 VIVITROL (naltrexone for extended-release injectable suspension), for intramuscular use 12/2/2019

Rockwell Medical, Inc

NDA 206317; NDA 208551 TRIFERIC (ferric pyrophosphate citrate) solution and TRIFERIC® (ferric pyrophosphate citrate) powder packet for addition to bicarbonate concentration 11/18/2019

Nascent Biotech, Inc.

Pritumumab 11/1/2019

Kowa Pharmaceuticals, Inc.

NDA 022363 Livalo (pitavastatin) tablet, for oral use 9/24/2019

Galt Pharmaceuticals, LLC

NDA 018708 DORAL (quazepam) tablets for oral use C-IV 9/13/2019

Metuchen Pharmaceuticals, LLC

NDA 202276 STENDRA (avanafil) tablets, for oral use 8/16/2019

CooperSurgical, Inc.

NDA 018680 ParaGard T380A INTRAUTERINE COPPER CONTRACEPTIVE 7/25/2019

Aclaris Therapeutics, Inc.

NDA 209305 ESKATA (hydrogen peroxide) topical solution 6/14/2019

VIVUS, Inc.

NDA 022580 QSYMIA (phentermine and topiramate extended-release) capsules, for oral use, CIV

5/22/2019

Phoenix Molecular Imaging Center

Sodium Acetate (C-11) 2/15/2019

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Office of Compliance/Immediate Office 

Company/Individual

Product/Issue

Issue Date

NuCare Pharmaceuticals Inc

non-compliance with listing obligations 9/26/2019

diphenhydramine hydrochloride and zinc acetate, NDC 41520-090; failure to address the listing deficiencies detailed in FDA’s letter to your company on March 19, 2019

7/11/2019

Yuyao Jessie Commodity Co., Ltd.

Mouth Fresh, NDC 51414-501/ failure to fulfill listing obligations 4/18/2019

ABC Compounding Co., Inc. 

Santi Wash Antiseptic Hand Wash, NDC 62257-275/ failure to fulfill listing obligations 4/18/2019

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Office of Manufacturing Quality

Company/Individual

Product/Issue

Issue Date

Apollo Health And Beauty Care, Inc.

CGMP/Finished Pharmaceuticals/Adulterated 12/23/2019

CGA Limited

CGMP/Finished Pharmaceuticals/Adulterated 12/19/2019

GPT Pharmaceuticals Private Ltd

CGMP/Finished Pharmaceuticals/Adulterated 12/17/2019

Baja Fur S.A. de C.V.

CGMP/Finished Pharmaceuticals/Adulterated 12/13/2019

Wild Child WA Pty Ltd.

CGMP/Finished Pharmaceuticals/Adulterated 12/6/2019

Tismor Health and Wellness Pty Limited

CGMP/Finished Pharmaceuticals/Adulterated 12/5/2019

Henan Kangdi Medical Devices Co. Ltd

CGMP/Finished Pharmaceuticals/Adulterated 12/3/2019

Greenbrier International, Inc dba Dollar Tree

CGMP/Finished Pharmaceuticals/Adulterated 11/6/2019

Mylan Laboratories Limited - Unit 8

CGMP/Active Pharmaceutical Ingredients (APIs)/Adulterated 11/5/2019

Cadila Healthcare Limited

CGMP/Finished Pharmaceuticals/Adulterated 10/29/2019

Coral Pharmaceuticals LTD

CGMP/Finished Pharmaceuticals/Adulterated 10/9/2019

Torrent Pharmaceuticals Limited

CGMP/Finished Pharmaceuticals/Adulterated 10/8/2019

Bingbing Pharmaceutical Co., Ltd

CGMP/Finished Pharmaceuticals/Adulterated 10/3/2019

Glenmark Pharmaceuticals Limited

CGMP/Finished Pharmaceuticals/Adulterated 10/3/2019

Dermameal Co., Ltd.

CGMP/Finished Pharmaceuticals 9/12/2019

Jiangsu NHWA Pharmaceutical Co., Ltd.

CGMP/Active Pharmaceutical Ingredients (APIs)/Adulterated 9/10/2019

Lupin Limited

CGMP/Finished Pharmaceuticals/APIs/Adulterated 9/10/2019

Hangzhou Badi Daily Use Chemical Company

CGMP/Finished Pharmaceuticals/APIs/Adulterated 8/29/2019

Shanghai Institute of Pharmaceutical Industry

CGMP/APIs 8/29/2019

Polimeros y Servicios S.A.

GMP/adulterated 8/22/2019

Haw Par Healthcare Limited

GMP/adulterated 8/19/2019

Ningbo Pulisi Daily Chemical Products Co., Ltd

CGMP/Finished Pharmaceuticals/Adulterated 8/13/2019

Yino, Inc.

GMP/adulterated 8/12/2019

Lantech Pharmaceuticals Limited

CGMP/Active Pharmaceutical Ingredients (APIs)/Adulterated 8/8/2019

NingBo Huize Commodity Co., Ltd.

CGMP/Finished Pharmaceuticals/Adulterated 8/2/2019

Deva Holding AS - Cerkezkoy Subesi

CGMP/Finished Pharmaceuticals/Adulterated 8/6/2019

Emcure Pharmaceuticals Limited

CGMP/Finished Pharmaceuticals/Adulterated 8/2/2019

CTX Lifesciences Private Ltd.

CGMP/Active Pharmaceutical Ingredients (APIs)/Adulterated 7/12/2019

Indoco Remedies Limited

CGMP/Finished Pharmaceuticals/Adulterated 7/9/2019
CGMP/Finished Pharmaceuticals/Adulterated 7/1/2019
CGMP/Active Pharmaceutical Ingredients (APIs)/Adulterated 6/20/2019

Rxhomeo Private Limited

CGMP/Finished Pharmaceuticals/Adulterated 6/13/2019

Xi'an Livingbond Nonwoven Products Corp., Ltd.

CGMP/Finished Pharmaceuticals/Adulterated 6/10/2019

Glint Cosmetics Pvt. Ltd.

CGMP/Finished Pharmaceuticals/Adulterated 5/31/2019

Vida International, Inc.

CGMP/Finished Pharmaceuticals/Adulterated 5/29/2019
CGMP/Finished Pharmaceuticals/Adulterated 5/7/2019

Centurion Laboratories Private Limited

CGMP/Finished Pharmaceuticals/Adulterated 5/4/2019

Laboratoires Clarins

CGMP/Finished Pharmaceuticals/Adulterated 4/23/2019

Luen Fook Medicine Sdn., Bhd.

CGMP/Finished Pharmaceuticals/Adulterated 4/4/2019

B. Jain Pharmaceuticals Private Limited

CGMP/Finished Pharmaceuticals/Adulterated 3/21/2019

Dong Yuan Technology Co., Ltd.

CGMP/Finished Pharmaceuticals/Adulterated

3/18/2019

Jubilant Life Sciences

CGMP/Finished Pharmaceuticals/Adulterated

3/6/2019

Hospira Healthcare India Pvt. Ltd

CGMP/Finished Pharmaceuticals/Adulterated 3/4/2019

Anicare Pharmaceuticals Pvt. Ltd.

CGMP/Finished Pharmaceuticals/Adulterated 2/28/2019

Proandre SL

CGMP/Finished Pharmaceuticals/Adulterated

2/13/2019

Vipor Chemicals Private Ltd.

CGMP/Active Pharmaceutical Ingredients (APIs)/Adulterated

1/29/2019

Hangzhou Sunking Nonwovens Co., Ltd.

CGMP/Finished Pharmaceuticals/Adulterated

1/29/2019

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Office of Scientific Investigations

Company/Individual

Product/Issue

Issue Date

Lymol Medical Corp

Postmarket Requirements (PMRs) 1/8/2019

Balamurali K. Ambati, M.D.

Sponsor/Investigator 9/3/2019

Susan P. King-Harris, D.P.M.

Bioresearch Monitoring Programs/IRB 9/17/2019

 

Office of Unapproved Drugs and Labeling Compliance

Company/Individual

Product/Issue

Issue Date

KOI CBD LLC

Unapproved drugs/Misbranded - “CBD HEALING BALM,” “CBD VAPE OIL,” “FULL SPECTRUM CBD TINCTURE,” “KOI LOTION,” “KOI CBD Gummies,” “KOI CBD Infused Shot” (three varieties), “KOI Naturals CBD Spray for Pets,” and “KOI CBD Soft Chews,” all of which you promote as products containing cannabidiol (CBD) 11/22/2019

Whole Leaf Organics, LLC

Unapproved drugs/Misbranded -   “CBD-EX,” “CBD MAX 1000 mg,” “CBD-RX,” “CBD Defend,” and “CBD Enflame,” all of which you promote as products containing cannabidiol (CBD) 11/22/2019

Mr. Pink Collections, LLC

Unapproved drugs/Misbranded -  “CBD Oil Drops” (various sizes and flavors), “CBD Gummies,” "CBD Vape Pen," and “Mr. Pink Natural CBD Oil for Pets” (also referred to as “Vegan Bacon Flavored Pet CBD Oil”), all of which you promote as products containing cannabidiol (CBD) 11/22/2019

Infinite Product Company LLLP DBA Infinite CBD

Unapproved drugs/Misbranded - “Absolute Zero 99% + CBD Isolate,” “Freezing Point CBD Topical Cream,” “Afterglow Healing Oil 100 mg CBD Total,” “Nano Enhancer Pure Nano CBD,” “Nano Freezing Point CBD Topical Cream,” “Asteroid Gummies,” “Sour Asteroid Gummies,” “Sweetened Dropper,” and “Nano Non Dairy Creamer,” all of which you promote as products containing cannabidiol (CBD) 11/22/2019

Sunflora, Inc./The CBD Store, LLC dba Your CBD Store

Unapproved drugs/Misbranded - “Sunmed Tincture” (also referred to as “0 THC Tinctures”), “Sunmed Water Soluble” (also referred to as “Water Soluble - 0 THC”), “Sunflora CBD Daytime Ageless Moisturizer” (also referred to as “CBD Daytime Moisturizer”), “Sunflora CBD Nighttime Ageless Serum” (also referred to as “CBD Nighttime Face Serum”), “Sunmed Topical Relief Cream” (also referred to as “Topical Pain Cream – Peppermint”), “SunMed Bacon Dog Treats,” “SunMed Pet Bark Bits Beef,” “SunMed Dog Lamb Bits,” and “SunMed Pet Tincture,” all of which you promote as products containing cannabidiol (CBD) 11/22/2019

Bella Rose Labs

Unapproved drugs/Misbranded - “BELLA ROSE HEMP OIL,” “CBD HEMP FACIAL MOISTURIZER,” “CBD ISOLATE,” “CBD TOPICAL,” “DISPOSABLE VAPE CARTIDGE CBD HEMP,” and “YUMMY BEARS GUMMIES,” all of which you promote as products containing cannabidiol (CBD) 11/22/2019

Noli Oil, LLC

“CBD Oil,” “CBD Oil Infused Balm," “CBD Roll-on Gel,” “CBD Organic Gummy Bears,” “CBD Infused Caramels,” “CBD Watermelon Rings,” “CBD Softgels,” “Repair with CBD, Collagen & Retinol” cream, “Tattoo Care Cream,” “Ultra Eye CBD Repair Cream,” “Face AM/PM Moisturizing Cream,” “CBD Soap,” “Refreshing & Revitalizing CBD Face Mask,” “Dog Treats (Beef Flavored)” and “Pet CBD Oil,” all of which you promote as products containing cannabidiol (CBD) 11/22/2019

EPH Technologies, Inc.

Unapproved drugs/Misbranded - “Detoxoplex,” “Sinoplex” and “Migrenza.” 11/18/2019

Rooted Apothecary LLC

“Teeth/TMJ – Essential Oil + CBD Infusion,” “Ears – Essential Oil + CBD Infusion,” “Hemp Capsules, 750 mg,” “Hemp Infused Body Butter,” and “Hemp Oil”/unapproved new drugs 10/10/2019

illegally marketing unapproved and misbranded versions of opioid medicines

9/6/2019

Polimeros y Servicios S.A.

Unapproved drugs/misbranded 8/22/2019

Haw Par Healthcare Limited

Unapproved drugs/misbranded 8/19/2019

Curaleaf, Inc

Unapproved New Drugs/Misbranded 7/22/2019

Cali Botanicals, LLC

Unapproved New Drugs/Misbranded 6/11/2019

Kratom NC

Unapproved New Drugs/Misbranded 5/16/2019

Advanced Spine and Pain, LLC (d/b/a Relievus)

Unapproved New Drugs/Misbranded 3/28/2019

Nutra Pure LLC

Unapproved New Drugs/Misbranded 3/28/2019

Nutra Pharma Corp.

Unapproved New Drugs/Misbranded

3/19/2019

Rablon

Unapproved New Drugs/Misbranded 3/8/2019

Office of Drug Security, Integrity and Recalls

Company/Individual

Product/Issue

Issue Date

 Aidaccess.org

Unapproved drugs/misbranded  3/8/2019

CanaRx Services Inc.

Unapproved drugs/misbranded 

2/26/2019

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