Inspections, Compliance, Enforcement, and Criminal Investigations

2017 Warning Letters

Letter Issue Date Company Name Issuing Office Subject Close Out Date
10/10/2017 Sohail M. Khan, M.D. Center for Drug Evaluation and Research Clinical Investigator Not Issued *
10/10/2017 US Compounding Inc Dallas District Office Compounding Pharmacy/Adulterated Drug Products Not Issued *
10/10/2017 Vital Laboratories Pvt Ltd Plant II Center for Drug Evaluation and Research CGMP/Active Pharmaceutical Ingredient (API)/Adulterated Not Issued *
10/06/2017 Rhodes Food Group (Pty) Ltd. Center for Food Safety and Applied Nutrition Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 10/05/2018
10/06/2017 Nexagen, LLC Atlanta District Office CGMP/Dietary Supplement/Adulterated Not Issued *
10/06/2017 Magadoo Corporation Co., Ltd. Center for Food Safety and Applied Nutrition Acidified Foods/Emergency Permit Control/Adulterated/Misbranded 02/07/2018
10/05/2017 Kelyniam Global, Inc. New England District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
10/04/2017 Custer Dairy Processing Plant Cincinnati District Office Food Labeling/Misbranded Not Issued *
10/04/2017 Vet Cellect Bio Products, LLC New Jersey District Office New Animal Drug/Adulterated Not Issued *
10/04/2017 Snyder's Lance Inc. Atlanta District Office Food Labeling/Misbranded/False and Misleading 08/24/2018
10/04/2017 Estiatorio Milos New York District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
10/03/2017 Talon Compounding Pharmacy Dallas District Office Compounding Pharmacy/Adulterated Drug Products Not Issued *
09/29/2017 Bush Brothers & Company Cincinnati District Office Low Acid Canned Food Regulation/Adulterated 05/07/2018
09/29/2017 http://www.911vape4less.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
09/29/2017 Nutritional Engineering Inc San Francisco District Office CGMP/Dietary Supplement/Adulterated/Misbranded Not Issued *
09/28/2017 Tuna Paradise Co. Ltd. Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 12/21/2017
09/28/2017 University Of Michigan Detroit District Office Drug Product/Adulterated Not Issued *
09/28/2017 Option Care Detroit District Office Drug Product/Adulterated Not Issued *
09/28/2017 Diasol Inc New England District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
09/28/2017 Total Body Nutrition New York District Office CGMP/Dietary Supplement/Adulterated/Misbranded Not Issued *
09/27/2017 Diasol Inc. Los Angeles District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
09/26/2017 http://www.ecigmates.co.uk Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Section 301(tt) Violation Not Issued *
09/26/2017 Ladd Family Pharmacy LLC Los Angeles District Office Compounding Pharmacy/Adulteration/Misbranding Not Issued *
09/26/2017 Douglas Chambers Dairy Inc. Atlanta District Office Illegal Drug Residue 08/24/2018
09/25/2017 San Diego Compounding Pharmacy Los Angeles District Office Compounding Pharmacy/Adulterated Drug Products Not Issued *
09/25/2017 UVLRX Therapeutics Inc Center for Devices and Radiological Health Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device Not Issued *
09/25/2017 Demetri's Coffee Service Cincinnati District Office CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated Not Issued *
09/22/2017 Nashoba Brook Bakery, LLC New York District Office CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
09/22/2017 Dasan E&T Co., Ltd. Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
09/22/2017 Texas Plum Line Dallas District Office Acidified Foods/Emergency Permit Control/Adulterated/Misbranded 05/03/2018
09/20/2017 ELITech Group B.V. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
09/20/2017 Loop Pharmacy & Home Medical New Jersey District Office Compounding Pharmacy/Adulterated Drug Products Not Issued *
09/20/2017 Euro Diagnostica AB Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated 09/14/2018
09/19/2017 J & B Seafood Inc. Cincinnati District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
09/19/2017 HA Stores, Ltd Center for Drug Evaluation and Research Unapproved New Drugs/Misbranded Not Issued *
09/19/2017 MyRXCash Center for Drug Evaluation and Research Unapproved New Drugs/Misbranded Not Issued *
09/19/2017 DRG Instruments GmbH Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *
09/19/2017 Rx-Partners Center for Drug Evaluation and Research Unapproved New Drugs/Misbranded Not Issued *
09/19/2017 Medicina Mexico Center for Drug Evaluation and Research Unapproved New Drugs/Misbranded Not Issued *
09/19/2017 Worldwide Drug Store Center for Drug Evaluation and Research Unapproved New Drugs/Misbranded Not Issued *
09/19/2017 PharmCash Center for Drug Evaluation and Research Unapproved New Drugs/Misbranded Not Issued *
09/19/2017 Pharmempire Center for Drug Evaluation and Research Unapproved New Drugs/Misbranded Not Issued *
09/19/2017 MediPK Center for Drug Evaluation and Research Unapproved New Drugs/Misbranded Not Issued *
09/19/2017 247Med Center for Drug Evaluation and Research Unapproved New Drugs/Misbranded Not Issued *
09/19/2017 Bulk2USA Center for Drug Evaluation and Research Unapproved New Drugs/Misbranded Not Issued *
09/19/2017 CanAmerica Global Center for Drug Evaluation and Research Unapproved New Drugs/Misbranded Not Issued *
09/19/2017 GlavMed Center for Drug Evaluation and Research Unapproved New Drugs/Misbranded Not Issued *
09/19/2017 American Pharmacy Group Center for Drug Evaluation and Research Unapproved New Drugs/Misbranded Not Issued *
09/18/2017 Strohecker's Pharmacy Los Angeles District Office Compounding Pharmacy/Adulterated Drug Products Not Issued *
09/18/2017 Compounded Solutions in Pharmacy New England District Office Compounding Pharmacy/Adulterated Drug Products Not Issued *

Page Last Updated: 04/22/2019
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English