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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
08/22/2013 John Brasil Dairy San Francisco District Office Illegal Drug Residue Not Issued *
08/21/2013 Dolphin Intertrade Corporation Florida District Office Unapproved and Misbranded New Drugs Not Issued *
08/21/2013 Dako Denmark A/S Center for Devices and Radiological Health Quality System Regulation for Medical Devices/Adulterated 04/15/2015
08/21/2013 Stewart Compounding Pharmacy Atlanta District Office CGMP/Finished Pharmaceuticals/Adulterated/Misbranded Not Issued *
08/19/2013 Good Fish Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
08/19/2013 www.snuscentral.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
08/16/2013 Vision RT Ltd Center for Devices and Radiological Health Quality System Regulation for Medical Devices/Adulterated Not Issued *
08/16/2013 Da'Vita Foods Company, Inc. Baltimore District Office CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions 03/31/2014
08/16/2013 Willow Farms New Orleans District Office PHS Act/Shell Egg Regulation/Adulterated Not Issued *
08/16/2013 Fenwal, a Fresenius-Kaby Company San Juan District Office CGMP/Finished Pharmaceuticals/Adulterated 04/23/2014
08/15/2013 The Centre for Reproductive Medicine Dallas District Office Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) Not Issued *
08/15/2013 Peyerk Brothers Dairy LLC Detroit District Office Illegal Drug Residue 02/09/2015
08/15/2013 Ulrich GmbH & Co. KG Center for Devices and Radiological Health Quality System Regulation/Adulterated/Medical Device Reporting/Misbranded Not Issued *
08/14/2013 Bob Gosman Co Inc dba Gosman's Fish Market, Inc. New York District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
08/13/2013 Metagenics Seattle District Office Medical Foods and New Drug Labeling/Internet Claims/Misbranded Not Issued *
08/13/2013 Soleetech Corporation Center for Devices and Radiological Health Quality System Regulation for Medical Device Reporting/Adulterated/Misbranded Not Issued *
08/12/2013 Deroyal Cientifica De Latinoamerica S.R.L. Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded 05/04/2015
08/12/2013 Carmack Industries LLC Seattle District Office Acidified Foods/Emergency Permit Control/Adulterated/Misbranded 08/04/2015
08/12/2013 Conair Corporation New England District Office CGMP/QSR/Medical Devices/Adulterated 03/23/2015
08/12/2013 Herbal Papaya Dallas District Office New Drug/Labeling/Misbranded Not Issued *
08/12/2013 Hubei Weikang Protective Products Co., Ltd. Center for Devices and Radiological Health Quality System Regulation for Medical Devices/Adulterated Not Issued *
08/09/2013 Hair Labs International, Inc. New Orleans District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
08/09/2013 LifeServe Blood Center Kansas City District Office CGMP Blood & Blood Components/Adulterated 07/02/2014
08/09/2013 Electro Medical, Inc Dallas District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
08/09/2013 Promed Exports Private Limited Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
08/09/2013 Sunrise Donuts, LLC Detroit District Office CGMP Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated   Not Issued *
08/09/2013 Zeppessis Reprocessing, LLC Seattle District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
08/09/2013 Native American Enterprises, LLC Kansas City District Office CGMP Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated Not Issued *
08/08/2013 The Reynolds Office of Health and Nutrition Center for Devices and Radiological Health Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) 04/09/2014
08/08/2013 Village Farm Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded 01/28/2015
08/08/2013 Carry All Provisions Inc Philadelphia District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 02/07/2014
08/08/2013 Pressure Tech Inc Center for Devices and Radiological Health Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) 04/09/2014
08/08/2013 Healing Dives, Inc. Center for Devices and Radiological Health Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) Not Issued *
08/08/2013 Hyperbaric Options Center for Devices and Radiological Health Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) Not Issued *
08/08/2013 Oxyhealth, LLC Center for Devices and Radiological Health Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) 04/08/2014
08/07/2013 Vibrant Life Los Angeles District Office New Drug/Labeling/Misbranded 03/19/2014
08/06/2013 Huestis Machine Corporation New England District Office CGMP/QSR/Medical Devices/Adulterated 05/21/2014
08/05/2013 NALMA, S.A. Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
08/05/2013 Country Bakery, LLC Denver District Office CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions 12/09/2013
08/02/2013 Posh Chemicals Private Limited Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated/HPLC Not Issued *
08/02/2013 DNE Nutraceuticals Inc. New Jersey District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
08/02/2013 T. Ho Foods, Inc. New Orleans District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
08/01/2013 Ontex Hygieneneartikel Gmbh Center for Devices and Radiological Health Quality System Regulation/Adulterated/Medical Device Reporting/Misbranded Not Issued *
08/01/2013 St Joseph Mercy Oakland IRB Center for Devices and Radiological Health Institutional Review Board (IRB) Not Issued *
08/01/2013 Lumina Health Products, Inc. Florida District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
07/31/2013 Wonjin Mulsan Co., Ltd. Center for Devices and Radiological Health Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) Not Issued *
07/31/2013 Peter Schiff Enterprises New Orleans District Office Quality System Regulation for Medical Devices/Adulterated Not Issued *
07/31/2013 Russell Hall Seafood, Inc. Baltimore District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
07/31/2013 LumiQuick Diagnostics Inc. San Francisco District Office Premarket Approval/Adulterated 10/19/2015
07/30/2013 Aarti Drugs Limited Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *

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