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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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2012 Warning Letters

Letter Issue Date Company Name Issuing Office Subject Close Out Date
August 03, 2012 The Crab Lady's Market New England District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions May 13, 2013
August 02, 2012 HSAC Enterprises, Inc. dba Kare-N-Herbs New England District Office Drug/Labeling/False & Misleading Claims September 10, 2012
August 02, 2012 Henrys Farm Inc. Baltimore District Office Insanitary Conditions/Adulterated Not Issued *
August 01, 2012 Endogastric Solutions, Inc. Center for Devices and Radiological Health Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Not Issued *
August 01, 2012 Bio Health Solutions San Francisco District Office Animal Drug/Adulterated Not Issued *
August 01, 2012 Compumedics Germany Gmbh Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Misbranded Not Issued *
August 01, 2012 Chu Minh Corp dba Chu Minh Tofu Seattle District Office CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions Not Issued *
July 31, 2012 Zarda Foods LLC Kansas City District Office CGMP/Manufacture/Packing/Storage/Installation/Adulterated Not Issued *
July 31, 2012 Bob's Red Mill Natural Foods, Inc. Seattle District Office Labeling/False & Misleading Claims/Misbranded Not Issued *
July 30, 2012 Infupharma, LLC Florida District Office CGMP for Finished Pharmaceutical/Adulterated June 26, 2013
July 30, 2012 Commed, Inc Seattle District Office CGMP for Medical Devices/QSR/Adulterated/Misbranded Not Issued *
July 30, 2012 Jiangsu Province Jianerkang Medical Dressing Co. Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
July 30, 2012 Grato, Inc. Kansas City District Office CGMP for Finished Pharmaceutical/Unapproved New Drugs/Adulterated/Misbranded Not Issued *
July 27, 2012 Damien Sanderlin, MD Center for Biologics Evaluation and Research Clinical Investigator Not Issued *
July 27, 2012 AireRx Healthcare, LLC New Orleans District Office CGMP for Medical Devices/QSR/Adulterated/Misbranded Not Issued *
July 27, 2012 Curry's Bakery Inc. dba Pastry Perfection Seattle District Office CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions February 19, 2013
July 26, 2012 Royal King Infant Products Co., Ltd. Center for Devices and Radiological Health Adultered Device/Misbranding  Not Issued *
July 26, 2012 Philippine Cinmic Industrial Corp Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated August 14, 2012
July 26, 2012 A Nelson & Co., Ltd. Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated/Misbranded Not Issued *
July 25, 2012 www.smoketobacco.net Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *



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