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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

Letter Issue Date Company Name Issuing Office Subject Close Out Date
August 21, 2013 Dako Denmark A/S Center for Devices and Radiological Health Quality System Regulation for Medical Devices/Adulterated Not Issued *
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 L.A. Lucky Import & Export Los Angeles District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
August 16, 2013 Fenwal, a Fresenius-Kaby Company San Juan District Office CGMP/Finished Pharmaceuticals/Adulterated 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 Willow Farms New Orleans District Office PHS Act/Shell Egg Regulation/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 15, 2013 Peyerk Brothers Dairy LLC Detroit District Office Illegal Drug Residue Not Issued *
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 Conair Corporation New England District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
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 12, 2013 Carmack Industries LLC Seattle District Office Acidified Foods/Emergency Permit Control/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 Not Issued *
August 09, 2013 Zeppessis Reprocessing, LLC Seattle District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
August 09, 2013 Sunrise Donuts, LLC Detroit District Office CGMP Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated   Not Issued *



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