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

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