Inspections, Compliance, Enforcement, and Criminal Investigations

2018 Warning Letters

Letter Issue Date Company Name Issuing Office Subject Close Out Date
05/18/2018 Front Range Kratom Center for Drug Evaluation and Research Unapproved New Drug/Misbranded Not Issued *
05/18/2018 Revibe, Inc. Center for Drug Evaluation and Research Unapproved New Drug/Misbranded Not Issued *
05/18/2018 Kratom Spot Center for Drug Evaluation and Research Unapproved New Drug/Misbranded Not Issued *
05/18/2018 Sunergized LLC Center for Food Safety and Applied Nutrition New Drug/Labeling/Misbranded Not Issued *
05/18/2018 CV7 Holdings LLC Center for Food Safety and Applied Nutrition New Drug/Labeling/Misbranded Not Issued *
05/18/2018 Pharmacy Direct, PDU Center for Food Safety and Applied Nutrition New Drug/Labeling/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 Napa Valley Bioscience Center for Food Safety and Applied Nutrition New Drug/Labeling/Misbranded Not Issued *
05/16/2018 New England Confectionery Company, Inc. Center for Food Safety and Applied Nutrition CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated Not Issued *
05/15/2018 Cerno Pharmaceutical Dallas District Office CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
05/10/2018 VallHund Vapes Inc. Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
05/10/2018 Virtue Vape, LLC Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
05/10/2018 13th Floor Elevapors, LLC Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
05/10/2018 Chill E-Liquid Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
05/09/2018 Montana Compounding Pharmacy PC Los Angeles District Office Compounding Pharmacy/Adulterated Drug Products Not Issued *
05/09/2018 Nox Bellcow Cosmetics Co. Ltd. Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
05/09/2018 Reine Lifescience Center for Drug Evaluation and Research CGMP/Active Pharmaceutical Ingredient (API)/Adulterated Not Issued *
05/07/2018 Emmett F. Branigan, MD, PS, Inc Los Angeles District Office Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) Not Issued *
05/01/2018 Sugoi LLC Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
05/01/2018 Tinted Brew, Inc Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
05/01/2018 Elite Vaporworks Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
05/01/2018 On Cloud Vape Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
05/01/2018 Fog It Up Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
05/01/2018 7 Daze, LLC Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
05/01/2018 Drip More LLC Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
05/01/2018 Ultimate Vape Deals Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
05/01/2018 NEwhere Inc. d/b/a Mad Hatter Juice Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
05/01/2018 Cosmic Fog Vapors LLC Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
05/01/2018 ACH Group, LLC d/b/a Candy Co E-Liquids Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
05/01/2018 Omnia E-Liquid Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
05/01/2018 Warrender Enterprise Inc. Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
04/30/2018 Chi's Enterprise Inc Los Angeles District Office CGMP/Dietary Supplement/Adulterated Not Issued *
04/25/2018 Baker's Best Health Products, Inc. Chicago District Office Unapproved New Drugs/Misbranded Not Issued *
04/25/2018 Hood River Juice Company, Inc. Seattle District Office Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
04/24/2018 Goran Pharma Pvt Ltd Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
04/19/2018 Southern Cloud Cartel LLC Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
04/19/2018 Lijiang Yinghua Biochemical and Pharmaceutical Co., Ltd. Center for Drug Evaluation and Research CGMP/Active Pharmaceutical Ingredient (API)/Adulterated Not Issued *
04/18/2018 Phase 4 Pharmaceutical LLC Dallas District Office CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
04/18/2018 MC Fish Co Cincinnati District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
04/18/2018 Herbs America, Inc. Seattle District Office New Drug/Misbranded Not Issued *
04/18/2018 Degasa S.A. De C.V. Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
04/16/2018 Ei LLC Dallas District Office CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
04/12/2018 The Sub Ohm Syndicate Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
04/09/2018 McCallum Manufacturing Ltd Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
04/06/2018 Luen Wah (HK) Medicine Ltd Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
04/06/2018 Results RNA, LLC Denver District Office Unapproved New Drugs/Misbranded Not Issued *
04/06/2018 Briar Shoppe, The Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
04/06/2018 http://www.cigarettes-mart.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
04/05/2018 RadLogics, Inc. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/PMA/Adulterated/Misbranded Not Issued *
04/04/2018 E-Jooce Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *

Page Last Updated: 05/27/2018
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