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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 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 13, 2012 Greens Wholesale Distributors, Inc. New Orleans District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
September 12, 2012 Winter Gardens Quality Foods, Inc. Philadelphia District Office Seafood HACCP/CGMP for Foods/Adulterated February 28, 2013
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 C.C. & Son Farms, Incorporated San Francisco District Office PHS Act/Violation/Adulterated Not Issued *
September 12, 2012 Lin-Ro Farms Philadelphia District Office Illegal Drug Residue March 05, 2013
September 12, 2012 Noble Anesthesia-Air, Inc. Florida District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
September 12, 2012 The Santa Barbara Smokehouse, Inc. Los Angeles District Office Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
September 12, 2012 St. James Smokehouse Florida District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions June 24, 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 11, 2012 Mir-Com Products LLC Philadelphia District Office CGMP/QSR/Medical Devices/Adulterated March 12, 2013
September 10, 2012 Global Source Management & Consulting Florida District Office New Drugs/Dietary Supplements/Food Labeling/Misbranded Not Issued *
September 10, 2012 Gyrus ACMI, Inc. New England District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
September 10, 2012 Monarch Seafoods, Inc. San Francisco District Office Seafood HACCP/CGMP for Foods/Adulterated November 25, 2013
September 07, 2012 www.cigarettes-for-less.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
September 07, 2012 Chassy Bagels, Inc. dba House of Bagels, Inc. San Francisco District Office CGMP For Manufacturing, Packing, or Holding Human Food/Adulterated Not Issued *
September 07, 2012 www.cheapindonesiacigarettes.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded November 07, 2012



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