Inspections, Compliance, Enforcement, and Criminal Investigations

2018 Warning Letters

Letter Issue Date Company Name Issuing Office Subject Close Out Date
09/12/2018 Vapor Unlimited, LLC d/b/a Fogworks Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
09/12/2018 E-Juice Vapor, Inc. Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
09/12/2018 Clouded Minds Vape Shoppe Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
09/12/2018 Metro Vapors, LLC Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
09/12/2018 FireVapor.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
09/12/2018 The Vapor Studio LLC Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
09/12/2018 Huntington Beach Vape Shop Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
09/12/2018 Aspen Valley Vapes Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
09/12/2018 TCA Vapor Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
09/12/2018 E Juice Forty Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
09/12/2018 Vapefu LLC Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
09/12/2018 Smoke and Vape Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
09/07/2018 ITG-Medev Inc San Francisco District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
09/07/2018 Best Nutrition Products, Inc. San Francisco District Office CGMP/Dietary Supplement/Adulterated/Misbranded Not Issued *
09/06/2018 Rose Acre Farms-Hyde County Atlanta District Office PHS Act/Shell Egg Regulation/Adulterated Not Issued *
09/06/2018 Adaptive Energy LLC Center for Food Safety and Applied Nutrition New Drug/Misbranded Not Issued *
09/05/2018 Samuel Zimmerman New York District Office PHS Act/Shell Egg Regulation/Adulterated Not Issued *
09/05/2018 Jabones Y Productos Especializados SA de CV Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
09/04/2018 Chillin Mix Kratom Center for Drug Evaluation and Research Finished Pharmaceuticals/Unapproved New Drug/Misbranded Not Issued *
09/04/2018 Mitra Distributing Inc. Center for Drug Evaluation and Research Finished Pharmaceuticals/Unapproved New Drug/Misbranded Not Issued *
09/04/2018 Natural Sea Product Co., Ltd. Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
09/04/2018 Lernapharm (Loris) Inc. Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
08/30/2018 Esmoker Canada Inc. Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
08/30/2018 SN Holdings, Inc. d/b/a 80V eLiquid Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
08/30/2018 My Vape DNA Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
08/30/2018 The Cigar Store Inc. Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
08/30/2018 West Coast Vape Supply, Inc Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
08/30/2018 Vapor Haus Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
08/30/2018 Dew Drops Eliquid Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
08/30/2018 X2 Cigs Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
08/30/2018 Precision Vapor Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
08/30/2018 Valencia Clouds Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
08/30/2018 Elev8 Vape Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
08/30/2018 Kick Bass Vapor Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
08/30/2018 Cigar Standard Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
08/30/2018 Flavour House Vapes Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
08/29/2018 Pharmaceutical Laboratories and Consultants, Inc. Detroit District Office CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
08/29/2018 Fagron, Inc Detroit District Office CGMP/Active Pharmaceutical Ingredient (API)/Adulterated Not Issued *
08/29/2018 Dolezal Dairy Kansas City District Office Illegal Drug Residue Animal Tissue/Adulterated/False Guaranty Not Issued *
08/28/2018 Celletech, Ltd Minneapolis District Office New Drugs/Dietary Supplements/Food Labeling/Misbranded Not Issued *
08/27/2018 Longood Medicine (Beijing) Co Ltd Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug Not Issued *
08/24/2018 Zimmer Biomet, Inc. New England District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
08/23/2018 Medtronic Puerto Rico Operations Co. Florida District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
08/20/2018 Tri-Coast Pharmacy Dallas District Office Compounding Pharmacy/Adulterated Drug Products Not Issued *
08/16/2018 PharmaMedics Center for Drug Evaluation and Research Finished Pharmaceuticals/Unapproved New Drug/Misbranded Not Issued *
08/16/2018 CoinRx Center for Drug Evaluation and Research Finished Pharmaceuticals/Unapproved New Drug/Misbranded Not Issued *
08/16/2018 PharmacyAffiliates.org Center for Drug Evaluation and Research Finished Pharmaceuticals/Unapproved New Drug/Misbranded Not Issued *
08/16/2018 MedInc.biz Center for Drug Evaluation and Research Finished Pharmaceuticals/Unapproved New Drug/Misbranded Not Issued *
08/15/2018 Healthy Healing dba Crystal Star Minneapolis District Office New Drug/Labeling/Misbranded Not Issued *
08/10/2018 Kyowa Hakko Bio Co., Ltd. Center for Drug Evaluation and Research CGMP/Active Pharmaceutical Ingredient (API)/Adulterated Not Issued *

Page Last Updated: 09/24/2018
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