Inspections, Compliance, Enforcement, and Criminal Investigations

2018 Warning Letters

Letter Issue Date Company Name Issuing Office Subject Close Out Date
07/09/2018 Roorda Dairy Kansas City District Office Food/Edible Tissue/Drug Residue/Adulterated Not Issued *
07/06/2018 Aegle Nutrition LLC Dallas District Office CGMP/Dietary Supplement/Adulterated/Misbranded Not Issued *
07/05/2018 Claris Injectables Limited Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
07/03/2018 AniCell Biotech Los Angeles District Office Unapproved New Animal Drug/Adultered Not Issued *
07/03/2018 bB BioChem Laboratories Inc. Los Angeles District Office CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug Not Issued *
06/29/2018 Holy Land Brand Inc. Minneapolis District Office CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated Not Issued *
06/27/2018 Zhuhai United Laboratories Co. Ltd. Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
06/26/2018 Foshan Jinxiong Technology Co., Ltd. Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
06/26/2018 American Chinese Medicine Association Detroit District Office New Drug/Misbranded Not Issued *
06/22/2018 Sichuan Friendly Pharmaceutical Co., Ltd. Center for Drug Evaluation and Research CGMP/Active Pharmaceutical Ingredient (API)/Adulterated Not Issued *
06/20/2018 KPC Products Inc Los Angeles District Office CGMP/Dietary Supplement/Adulterated/Misbranded Not Issued *
06/12/2018 Henan Lihua Pharmaceutical Co., Ltd. Center for Drug Evaluation and Research CGMP/Active Pharmaceutical Ingredient (API)/Adulterated Not Issued *
06/12/2018 Ami Cosmetics Co., Ltd. Center for Drug Evaluation and Research Failure to Comply with Drug Listing Requirements/Misbranded Not Issued *
06/11/2018 LNZRO Pizza Empire, Inc. New York District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
06/08/2018 Kaltec Food Packaging Inc. New York District Office Acidified Foods/Emergency Permit Control/Adulterated/Misbranded Not Issued *
06/08/2018 BR SAS Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
06/07/2018 Up Inya Gear Center for Food Safety and Applied Nutrition New Drug/Misbranded Not Issued *
06/06/2018 The Health Management Group Inc. Cincinnati District Office CGMP/Dietary Supplement/Adulterated/Misbranded Not Issued *
05/31/2018 Hells Vapors LLC Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
05/31/2018 Vapestar Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
05/31/2018 Taiwan Biotech Co., LTD. Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
05/31/2018 Global Vapery Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
05/31/2018 Jacobs Pills, Inc. New Jersey District Office Compounding Pharmacy/Adulterated Drug Products Not Issued *
05/31/2018 Fair Fish Co., Inc. New York District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
05/31/2018 Northwoods Vape Escape LLC Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
05/30/2018 JSST Enterprises LLC Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
05/30/2018 Savage Juice Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
05/30/2018 Blowing Vapors Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
05/30/2018 Swamp Vapor Lafayette Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
05/30/2018 Hi Five Ohm Vape Co Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
05/29/2018 Eassybuyonline Center for Drug Evaluation and Research Finished Pharmaceuticals/Unapproved New Drug/Misbranded Not Issued *
05/29/2018 LiquidCaffeine.com Center for Food Safety and Applied Nutrition Dietary Supplement/Adulterated Not Issued *
05/29/2018 XLPharmacy Center for Drug Evaluation and Research Finished Pharmaceuticals/Unapproved New Drug/Misbranded Not Issued *
05/29/2018 RxCash.Biz Center for Drug Evaluation and Research Finished Pharmaceuticals/Unapproved New Drug/Misbranded Not Issued *
05/29/2018 Medstore.biz Center for Drug Evaluation and Research Finished Pharmaceuticals/Unapproved New Drug/Misbranded Not Issued *
05/29/2018 AnonShop Center for Drug Evaluation and Research Finished Pharmaceuticals/Unapproved New Drug/Misbranded Not Issued *
05/29/2018 Dual Health Body and Mind Center for Food Safety and Applied Nutrition Dietary Supplement/Adulterated Not Issued *
05/29/2018 Instabill ECS‐Rx Center for Drug Evaluation and Research Finished Pharmaceuticals/Unapproved New Drug/Misbranded Not Issued *
05/29/2018 TramadolHub Center for Drug Evaluation and Research Finished Pharmaceuticals/Unapproved New Drug/Misbranded Not Issued *
05/29/2018 RemedyMart Center for Drug Evaluation and Research Finished Pharmaceuticals/Unapproved New Drug/Misbranded Not Issued *
05/29/2018 One Stop Pharma Center for Drug Evaluation and Research Finished Pharmaceuticals/Unapproved New Drug/Misbranded Not Issued *
05/24/2018 Bimeda, Inc. Center for Veterinary Medicine False & Misleading Claims/Misbranded Not Issued *
05/24/2018 The Fertility Partnership LLC Chicago District Office Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) Not Issued *
05/23/2018 IDT Australia Ltd. Center for Drug Evaluation and Research CGMP/Active Pharmaceutical Ingredient (API)/Adulterated Not Issued *
05/23/2018 Creative Science, Inc. Detroit District Office Human Drug/Marketing/Animal Drug/Unsafe/Adulterated Not Issued *
05/21/2018 Oeyama-Moto-Medical Group Foundation, LLC Center for Drug Evaluation and Research Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies Not Issued *
05/18/2018 Kratom Spot Center for Drug Evaluation and Research Unapproved New Drug/Misbranded Not Issued *
05/18/2018 GliSODin Skin Nutrients Center for Food Safety and Applied Nutrition New Drug/Labeling/Misbranded Not Issued *
05/18/2018 Sunergized LLC Center for Food Safety and Applied Nutrition New Drug/Labeling/Misbranded 06/19/2018
05/18/2018 Revibe, Inc. Center for Drug Evaluation and Research Unapproved New Drug/Misbranded Not Issued *

Page Last Updated: 07/18/2018
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