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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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2017 Warning Letters

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Letter Issue Date Company Name Issuing Office Subject Close Out Date
03/13/2017 South Fork Dairy, LLC Cincinnati District Office Illegal Drug Residue Not Issued *
03/10/2017 USV Limited Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
03/07/2017 Ark Bio Medical Canada Corp Center for Biologics Evaluation and Research Premarket Approval/Misbranded/Adulterated Not Issued *
03/02/2017 Badrivishal Chemicals & Pharmaceuticals Center for Drug Evaluation and Research CGMP/Active Pharmaceutical Ingredient (API)/Adulterated/Misbranded Not Issued *
03/02/2017 Lumis Global Pharmaceuticals Co. Ltd. Center for Drug Evaluation and Research CGMP/Active Pharmaceutical Ingredient (API)/Adulterated/Misbranded Not Issued *
03/02/2017 Cape Fear Naturals Atlanta District Office CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
03/02/2017 Lucky Pacific Corp and Kamli International Co. Ltd. New York District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
03/02/2017 Holdgrafer Dairy Inc. Kansas City District Office Illegal Drug Residue Animal Tissue/Adulterated Not Issued *
03/01/2017 Bond Pharmacy, Inc. dba Advanced Infusion Solutions New Orleans District Office Drug/Prepared, Packed or Held Under Insanitary Conditions/Adulterated Not Issued *
02/28/2017 Trapper's Creek Inc. DBA Copper River Smoking Company Seattle District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
02/28/2017 TS Food Industry Sdn. Bhd. Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
02/27/2017 DeGrave Dairy Minneapolis District Office Illegal Drug Residue Not Issued *
02/24/2017 Nutrishop dba Natural Generation Nutrition New Jersey District Office CGMP/Dietary Supplement/Adulterated/Misbranded Not Issued *
02/24/2017 Megafine Pharma (P) Limited Center for Drug Evaluation and Research CGMP/Active Pharmaceutical Ingredient (API)/Adulterated Not Issued *
02/24/2017 Jinan Jinda Pharmaceutical Chemistry Co., Ltd. Center for Drug Evaluation and Research CGMP/Active Pharmaceutical Ingredient (API)/Adulterated Not Issued *
02/23/2017 Modern Macaroni Co Ltd San Francisco District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
02/23/2017 Denttio, Inc. Los Angeles District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
02/17/2017 Orlando Vape Bar, LLC Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Misbranding Not Issued *
02/17/2017 Pirate VapeStore Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Misbranding Not Issued *
02/17/2017 Tobacco Stock Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Misbranding Not Issued *
02/17/2017 Apache Vape Limited Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Misbranding Not Issued *
02/17/2017 Morton Grove Pharmaceuticals, Inc. Chicago District Office CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
02/17/2017 N2G2, LLC Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Misbranding Not Issued *
02/17/2017 Tiki Vapes Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
02/17/2017 Vaping Outlaws London Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Misbranding Not Issued *
02/17/2017 Aegeia Skin Care, LLC Dallas District Office New Drugs/Cosmetics Labeling and Marketing with Drug Claims Not Issued *
02/16/2017 TJSL-Investments Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Misbranding Not Issued *
02/16/2017 Hurley's Vapor Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Misbranding Not Issued *
02/16/2017 Downtown Cigar Bar Fort Lauderdale Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Misbranding Not Issued *
02/16/2017 Smarter Smokes Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Misbranding Not Issued *
02/16/2017 www.vap-cafe.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
02/14/2017 Hospira Inc Kansas City District Office CGMP/Drugs/Adulterated Not Issued *
02/14/2017 Chongqing Pharma Research Institute Co., Ltd. Center for Drug Evaluation and Research CGMP/Active Pharmaceutical Ingredient (API)/Adulterated Not Issued *
02/10/2017 Apple Tree Goat Dairy Philadelphia District Office CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated/L. monocytogenes Not Issued *
02/08/2017 Humaworm New Orleans District Office Unapproved New Drugs/Misbranded Not Issued *
02/08/2017 Fred & Tyler Kamp Dallas District Office New Animal Drug/Adulterated Not Issued *
02/08/2017 Southern Aire Seafood, Inc. Nashville District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
02/07/2017 Dorneyville Pharmacy Philadelphia District Office Compounding Pharmacy/Adulterated Drug Products Not Issued *
02/03/2017 Kumato Labs Los Angeles District Office CGMP/Dietary Supplement/Adulterated/Misbranded Not Issued *
02/03/2017 ProSupps USA LLC Dallas District Office CGMP/Dietary Supplement/Adulterated/Misbranded Not Issued *
02/03/2017 Resonance Laboratories Private Limited Center for Drug Evaluation and Research CGMP/Active Pharmaceutical Ingredient (API)/Adulterated Not Issued *
02/03/2017 MBDR Foods, LLC Kansas City District Office Acidified Foods/Prepared Packed or Held Under Insanitary Conditions Not Issued *
02/02/2017 Sato Pharmaceutical Co., Ltd. Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
02/01/2017 Life Extension Foundation Buyers Club, Inc. Florida District Office New Drug/Labeling/Misbranded Not Issued *
01/31/2017 Berkeley Nutritional Mfg Corp. San Francisco District Office CGMP/Finished Pharmaceuticals/Adulterated/Misbranded Not Issued *
01/31/2017 Ausmetics Daily Chemicals (Guangzhou) Co., Ltd Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
01/30/2017 Bao International Inc Los Angeles District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
01/26/2017 WD Import and Export Inc. New York District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
01/26/2017 Zhejiang Bangli Medical Products Co., Ltd Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
01/26/2017 Humco Holding Group, Inc Dallas District Office CGMP/Finished Pharmaceuticals/Adulterated/Misbranded Not Issued *

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