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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
September 14, 2012 Oregon Aesthetic Technologies, Inc. Seattle District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
September 13, 2012 Greens Wholesale Distributors, Inc. New Orleans District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
September 13, 2012 Archie Domina Farm New England District Office Illegal Drug Residue Not Issued *
September 13, 2012 Nick & Katie's, Inc New Orleans District Office Low Acid Canned Food Regulation/Adulterated December 10, 2013
September 12, 2012 St. James Smokehouse Florida District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions June 24, 2013
September 12, 2012 Winter Gardens Quality Foods, Inc. Philadelphia District Office Seafood HACCP/CGMP for Foods/Adulterated February 28, 2013
September 12, 2012 The Santa Barbara Smokehouse, Inc. Los Angeles District Office Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
September 12, 2012 DMC Medical Technology & Manufacturing Co., Ltd. Center for Devices and Radiological Health Quality System Regulation for Medical Devices/Adulterated Not Issued *
September 12, 2012 Lin-Ro Farms Philadelphia District Office Illegal Drug Residue March 05, 2013
September 12, 2012 C.C. & Son Farms, Incorporated San Francisco District Office PHS Act/Violation/Adulterated Not Issued *
September 12, 2012 Noble Anesthesia-Air, Inc. Florida District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
September 11, 2012 Mir-Com Products LLC Philadelphia District Office CGMP/QSR/Medical Devices/Adulterated March 12, 2013
September 11, 2012 EPS Biotechnology Corp. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated October 31, 2013
September 11, 2012 Roberts Ranch of Oklahoma LLC Dallas District Office Illegal Drug Residue September 25, 2013
September 10, 2012 Monarch Seafoods, Inc. San Francisco District Office Seafood HACCP/CGMP for Foods/Adulterated November 25, 2013
September 10, 2012 Gyrus ACMI, Inc. New England District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
September 10, 2012 Global Source Management & Consulting Florida District Office New Drugs/Dietary Supplements/Food Labeling/Misbranded Not Issued *
September 07, 2012 Unisis Corporation Center for Devices and Radiological Health CGMP/QSR/Medical Device Reporting/Adulterated/Misbranded Not Issued *
September 07, 2012 www.cheapindonesiacigarettes.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded November 07, 2012
September 07, 2012 Greek Island Labs Center for Food Safety and Applied Nutrition New Drug Application [NDA] Not Issued *



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