Inspections, Compliance, Enforcement, and Criminal Investigations

2017 Warning Letters

Letter Issue Date Company Name Issuing Office Subject Close Out Date
03/15/2017 Chen Shwezin, Inc. dba Park Compounding Pharmacy Los Angeles District Office Compounding Pharmacy/Adulterated Drug Products Not Issued *
03/15/2017 Country Favor Inc. New York District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
03/13/2017 SK Food Group San Francisco District Office CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated/L. monocytogenes 08/13/2018
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 02/14/2018
03/09/2017 C & B Croissants Corporation Los Angeles District Office CGMP Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated   Not Issued *
03/09/2017 Reliable Rexall-A Compounding Pharmacy San Francisco District Office Compounding Pharmacy/Adulterated Drug Products Not Issued *
03/07/2017 Sweet Springs Valley Water Co., Inc. Baltimore District Office Processing and Bottling of Bottled Drinking Water Regulation/Insanitary Conditions Not Issued *
03/07/2017 Sucesores De Esmoris & Co., Inc. San Juan District Office CGMP Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated   Not Issued *
03/07/2017 Ark Bio Medical Canada Corp Center for Biologics Evaluation and Research Premarket Approval/Misbranded/Adulterated Not Issued *
03/03/2017 The Cookie Boys San Francisco District Office CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated 05/31/2018
03/02/2017 Badrivishal Chemicals & Pharmaceuticals 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 Lumis Global Pharmaceuticals Co. Ltd. Center for Drug Evaluation and Research CGMP/Active Pharmaceutical Ingredient (API)/Adulterated/Misbranded Not Issued *
03/02/2017 Holdgrafer Dairy Inc. Kansas City District Office Illegal Drug Residue Animal Tissue/Adulterated
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 *
03/01/2017 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 07/24/2018
02/28/2017 TS Food Industry Sdn. Bhd. Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 08/29/2017
02/27/2017 DeGrave Dairy Minneapolis District Office Illegal Drug Residue Not Issued *
02/27/2017 Invitrx Therapeutics, Inc Los Angeles District Office New Drug/Labeling/Misbranded Not Issued *
02/27/2017 SNAC System Inc. San Francisco District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated
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 Denttio, Inc. Los Angeles District Office CGMP/QSR/Medical Devices/Adulterated 04/10/2018
02/23/2017 Modern Macaroni Co Ltd San Francisco District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
02/23/2017 G L E Gesellschaft Fur Lichttechnische Erzeugnisse Mbh Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *
02/17/2017 Tobacco Stock Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
02/17/2017 Orlando Vape Bar, LLC Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
02/17/2017 Apache Vape Limited 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/Adulterated/Misbranded Not Issued *
02/17/2017 Pirate VapeStore Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded 04/13/2017
02/17/2017 N2G2, LLC Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
02/17/2017 Aegeia Skin Care, LLC Dallas District Office New Drugs/Cosmetics Labeling and Marketing with Drug Claims 05/17/2018
02/17/2017 Tiki Vapes Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
02/17/2017 Morton Grove Pharmaceuticals, Inc. Chicago District Office CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
02/16/2017 TJSL-Investments Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
02/16/2017 Hurley's Vapor Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
02/16/2017 Downtown Cigar Bar Fort Lauderdale Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
02/16/2017 Smarter Smokes Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded 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 Chongqing Pharma Research Institute Co., Ltd. Center for Drug Evaluation and Research CGMP/Active Pharmaceutical Ingredient (API)/Adulterated Not Issued *
02/14/2017 Hospira Inc Kansas City District Office CGMP/Drugs/Adulterated 06/27/2018
02/14/2017 The See Clear Company Atlanta District Office CGMP/QSR/Medical Devices/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. New Orleans 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 ProSupps USA LLC Dallas District Office CGMP/Dietary Supplement/Adulterated/Misbranded Not Issued *

Page Last Updated: 04/22/2019
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