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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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2013 Warning Letters

 
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Letter Issue Date Company Name Issuing Office Subject Close Out Date
12/31/2013 John Balbian New York District Office Illegal Drug Residue Not Issued *
12/31/2013 Buchanan Manufacturing Inc New Orleans District Office Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 01/06/2015
12/31/2013 Mapa Gmbh Center for Devices and Radiological Health Medical Device Reporting/Adulterated/Misbranding 04/09/2015
12/31/2013 Prestige Chinese Teas Company, Inc. San Francisco District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
12/26/2013 NVN Therapeutics Center for Food Safety and Applied Nutrition Medical Foods/Unapproved New Drug/Misbranded Not Issued *
12/26/2013 Accera, Inc. Center for Food Safety and Applied Nutrition Medical Foods/Unapproved New Drug/Misbranded Not Issued *
12/20/2013 Drucker Labs LP Dallas District Office CGMP/Dietary Supplement/Adulterated/Therapeutic Claims Not Issued *
12/20/2013 Star Scientific, Inc. Center for Food Safety and Applied Nutrition Unapproved and Misbranded New Drugs, Anatabloc and CigRx 10/21/2014
12/20/2013 www.cheapcigarettes2013.net Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded 04/03/2014
12/20/2013 Philips Healthcare Los Angeles District Office Medical Device Reporting/Misbranded Not Issued *
12/20/2013 DNA Genotek Inc. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
12/19/2013 Three L Farm New York District Office Illegal Drug Residue Not Issued *
12/19/2013 Baxter Healthcare Corporation Los Angeles District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
12/18/2013 China Cigarette Manufacture Co., Ltd Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded 03/18/2014
12/18/2013 www.cigarettesplace.com Center for Tobacco Products Modified Risk Tobacco Products Not Issued *
12/17/2013 Amplion Clinical Communications Inc New Orleans District Office CGMP/QSR/Medical Devices/Adulterated 06/12/2014
12/17/2013 Christopher F. Anderson New York District Office Illegal Drug Residue Not Issued *
12/16/2013 Subcon Manufacturing Corporation Chicago District Office Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) 05/05/2014
12/16/2013 Quality Beef Company, Inc. New England District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 05/23/2016
12/13/2013 Comercial Comtesa S.A. Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
12/13/2013 G and G Peppers Detroit District Office Low Acid Canned Food Regulation/Adulterated/Insanitary Conditions 06/12/2015
12/13/2013 PARAYIL FOOD PRODUCTS PVT. LTD. Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
12/13/2013 Pesquera Alvarez y Alvarez Ltda Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
12/13/2013 Krier Foods, Inc. Minneapolis District Office CGMP/Dietary Supplement/Adulterated/Misbranded 07/18/2014
12/13/2013 AFP Advanced Food Products Llc Minneapolis District Office Low Acid Canned Food Regulation/Adulterated 06/09/2014
12/12/2013 Florida Fertility Institute Florida District Office Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) 08/21/2014
12/12/2013 SKINREX CO., LTD Center for Devices and Radiological Health Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) Not Issued *
12/12/2013 Racer Technology Pte Ltd Center for Devices and Radiological Health Quality System Regulation for Medical Devices/Adulterated 07/16/2015
12/12/2013 Health Breakthrough International, LLC Seattle District Office CGMP/Dietary Supplement/Adulterated/Misbranded Not Issued *
12/12/2013 DNO Inc Cincinnati District Office CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated Not Issued *
12/11/2013 Coastal Contacts Inc. Center for Devices and Radiological Health Quality System Regulation/Adulterated/Medical Device Reporting/Misbranded 07/16/2015
12/11/2013 Dutch-Maid Bakery New Orleans District Office CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions Not Issued *
12/09/2013 Mayor Laboratories Inc Los Angeles District Office CGMP/Dietary Supplement/Adulterated/Misbranded Not Issued *
12/06/2013 Eagle New York New Jersey District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 05/02/2014
12/05/2013 Green Planet Inc Los Angeles District Office Unapproved and Misbranded New Drugs 11/12/2014
12/05/2013 Osaki Suisan Co., Ltd. Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
12/04/2013 Mommy Gina Tuna Resources (MGTR), Inc Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
12/04/2013 PurQuality, LLC Los Angeles District Office CGMP/Dietary Supplement/Adulterated/Misbranded Not Issued *
12/04/2013 Rehabtronics Inc. Center for Devices and Radiological Health Quality System Regulation for Medical Devices/Adulterated Not Issued *
12/04/2013 Hubbard Feeds, Inc. Detroit District Office CGMP/Medicated Feeds/Adulterated 01/22/2015
12/04/2013 Smith Dairy Cincinnati District Office Illegal Drug Residue Not Issued *
12/04/2013 Himmelspach, William W. Seattle District Office Illegal Drug Residue Not Issued *
12/03/2013 Caldwell Animal Hospital New Orleans District Office Illegal Drug Residue Not Issued *
12/03/2013 Van Erk Dairy LLC Cincinnati District Office Illegal Drug Residue Not Issued *
12/03/2013 Burzynski Research Institute Center for Drug Evaluation and Research Sponsor/Monitor/Contract Research Organization Not Issued *
12/03/2013 Burzynski, Stanislaw R. MD Center for Drug Evaluation and Research Clinical Investigator Not Issued *
12/03/2013 Thang Nguan Hah Co., Ltd. Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
12/02/2013 Market Technologies Inc. DBA Dermavista New Orleans District Office Medical Device Reporting/Misbranded Not Issued *
12/02/2013 Ameriderm Laboratories, Ltd. New Jersey District Office CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
11/29/2013 Velmahos, George C. M.D., Ph.D Center for Biologics Evaluation and Research Clinical Investigator - Human Trials 01/03/2014

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