Inspections, Compliance, Enforcement, and Criminal Investigations

2018 Warning Letters

Letter Issue Date Company Name Issuing Office Subject Close Out Date
12/14/2018 Longbow First Aid Products Manufactory Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
12/14/2018 Hangzhou Guoguang Touring Commodity Co.,Ltd. Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
12/13/2018 Soleo Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
12/13/2018 Samson Pharmaceuticals, Inc. Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
12/03/2018 University of Miami Reproductive and Fertility Center Center for Biologics Evaluation and Research Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) Not Issued *
12/03/2018 Skylark CMC Pvt. Ltd. Center for Drug Evaluation and Research Drug Product/Adulterated Not Issued *
11/30/2018 Mountain Vapor LLC Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
11/30/2018 Vapor House LLC Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
11/30/2018 Aladin Shisha Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
11/30/2018 CAO Medical Equipment Co., Ltd. Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
11/30/2018 Hybrid Pharma, LLC Center for Drug Evaluation and Research Compounding Pharmacy/Adulteration/Misbranding Not Issued *
11/29/2018 Zhejiang Huahai Pharmaceutical Center for Drug Evaluation and Research CGMP/Active Pharmaceutical Ingredient (API)/Adulterated Not Issued *
11/29/2018 Electric Lotus, LLC Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
11/29/2018 Gonzalez and Nietos, LLC San Juan District Office Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
11/29/2018 Genetech Inc Center for Biologics Evaluation and Research Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) Not Issued *
11/28/2018 Barox Co., Ltd. Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
11/27/2018 Welter Farms Inc Center for Veterinary Medicine Food/Prepared Packed or Held Under Insanitary Conditions/Adulterated Not Issued *
11/27/2018 Hangzhou Zhongbo Industrial Co., Ltd. Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
11/20/2018 Mibo Medical Group San Francisco District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
11/19/2018 Jelliffe Dairy Farm Baltimore District Office Illegal Drug Residue Animal Tissue/Adulterated Not Issued *
11/16/2018 Corona Doctors Medical Clinics Center for Drug Evaluation and Research Medical Foods/Unapproved New Drug/Misbranded Not Issued *
11/15/2018 H & H Products Company San Juan District Office Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
11/09/2018 Mylan Pharmaceuticals Inc. Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
11/08/2018 Avalon Packaging Denver District Office New Drugs/Dietary Supplements/Food Labeling/Misbranded Not Issued *
11/08/2018 Guardian Pet Products Center for Veterinary Medicine Labeling/Unapproved New Animal Drug/Adulterated Not Issued *
11/07/2018 MA Labs LLC Center for Food Safety and Applied Nutrition Unapproved New Drugs/Misbranded Not Issued *
11/07/2018 Jack B Goods Outlet Store Center for Food Safety and Applied Nutrition Unapproved New Drugs/Misbranded Not Issued *
11/06/2018 Ruben's Inc. Denver District Office CGMP Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated   Not Issued *
11/06/2018 Surmasis Pharmaceutical Detroit District Office CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
11/06/2018 American Contract Systems New England District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
11/02/2018 Product Packaging West, Inc. San Francisco District Office CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
10/31/2018 StemGenex Biologic Laboratories, LLC Center for Biologics Evaluation and Research Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) Not Issued *
10/31/2018 DynaPro International, Inc. Denver District Office Dietary Supplement/New Drug/Misbranded Not Issued *
10/30/2018 Human Biologics of Texas/Globus Medical Los Angeles District Office Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) Not Issued *
10/30/2018 American Botanical Pharmacy San Francisco District Office Unapproved New Drugs/Misbranded Not Issued *
10/29/2018 I. Shay Cosmetics Inc San Francisco District Office CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
10/29/2018 Netcos Co., Ltd. Center for Drug Evaluation and Research Failure to Register and List 11/30/2018
10/29/2018 United Exchange Corporation Center for Drug Evaluation and Research Failure to Register and List 11/30/2018
10/26/2018 EMSP LTD d/b/a My Shisha Pen Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
10/26/2018 Greenpark Compounding Pharmacy Center for Drug Evaluation and Research Drug Product/Adulterated Not Issued *
10/26/2018 Alle Processing Corp. Center for Food Safety and Applied Nutrition Low Acid Canned Food Regulation/Adulterated Not Issued *
10/26/2018 Specialty Tobacco, Inc Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
10/26/2018 Cano Tobacco Inc. Center for Tobacco Products Drug Product/Adulterated Not Issued *
10/26/2018 LA Tobacco, Inc. Center for Tobacco Products Device/Adulterated Not Issued *
10/19/2018 5 Spoke Creamery, LLC Center for Food Safety and Applied Nutrition Food/Prepared Packed or Held Under Insanitary Conditions/Adulterated Not Issued *
10/19/2018 Premier Produce LLC Cincinnati District Office CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated Not Issued *
10/19/2018 Lakeview Dairy, LLC Minneapolis District Office Illegal Drug Residue Not Issued *
10/19/2018 Gold Star Distrbution., Inc. Minneapolis District Office CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated Not Issued *
10/18/2018 Custom RX LLC dba Custom Rx Pharmacy and Wellness Concepts Detroit District Office Compounding Pharmacy/Adulterated Drug Products Not Issued *
10/17/2018 Ocular Therapeutix Inc. Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated Not Issued *

Page Last Updated: 03/21/2019
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