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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
March 05, 2012 Breathable Foods, Inc. New England District Office False & Misleading Claims/Misbranded Not Issued *
March 02, 2012 General Tuna Corporation Center for Food Safety and Applied Nutrition Seafood HACCP/Adulterated Not Issued *
March 02, 2012 Hill-Rom, Inc. Detroit District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
March 02, 2012 Dorsey Farms, Inc. Seattle District Office Illegal Drug Residue Not Issued *
March 02, 2012 Fog River, LLC Denver District Office Seafood HACCP/CGMP for Foods/Adulterated November 21, 2012
February 28, 2012 Prosec Protection Systems, Inc. New Jersey District Office CGMP for Medical Devices/QS/Adulterated Not Issued *
February 28, 2012 Pan Drugs Limited Center for Drug Evaluation and Research Failure to Register and List October 18, 2012
February 27, 2012 Sir Pizza of Tennessee, Inc. New Orleans District Office Current Good Manufacturing Practice in Manufacturing Packing or Holding Human Food/Adulterated June 14, 2012
February 24, 2012 Butternut Brook Farm New York District Office Illegal Drug Residue Not Issued *
February 24, 2012 Extremity Medical, LLC New Jersey District Office Medical Device Reporting Regulation/Adulterated/Misbranded November 26, 2012
February 24, 2012 Fells Point Wholesale Meats, Inc. Baltimore District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
February 23, 2012 Innovatech Medical Resources L.P. d/b/a Medical Services International (MSI) Dallas District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
February 23, 2012 Gulf Pharmaceutical Industries Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated, Not Issued *
February 23, 2012 Medica-Rents Co., Ltd. Dallas District Office CGMP/QSR/Medical Devices/Adulterated January 29, 2013
February 23, 2012 Life Recovery Systems HD, LLC New Jersey District Office CGMP/QSR/Medical Devices/Adulterated September 25, 2012
February 23, 2012 Wintac Limited Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated June 18, 2014
February 23, 2012 Shanghai Apolo Medical Technology Co., Ltd Center for Devices and Radiological Health Adulterated Device Not Issued *
February 23, 2012 Lucomed Spa Center for Devices and Radiological Health CMGP for Medical Devices/QSR/Medical Device Reporting/Misbranded Not Issued *
February 22, 2012 Dale's LLC Denver District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions May 22, 2014
February 22, 2012 APP Pharmaceuticals, LLC New York District Office CGMP for Finished Pharmaceuticals/Adulterated Not Issued *



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