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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 EMG Manufacturing Co., Ltd. Center for Devices and Radiological Health CGMP/QSR/Medical Device Reporting/Adulterated/Misbranded 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 13, 2012 Archie Domina Farm New England District Office Illegal Drug Residue Not Issued *
September 12, 2012 C.C. & Son Farms, Incorporated San Francisco District Office PHS Act/Violation/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 Winter Gardens Quality Foods, Inc. Philadelphia District Office Seafood HACCP/CGMP for Foods/Adulterated February 28, 2013
September 12, 2012 Lin-Ro Farms Philadelphia District Office Illegal Drug Residue March 05, 2013
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 12, 2012 Noble Anesthesia-Air, Inc. Florida District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
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 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 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 Fercy Personal Care Products Co., Ltd Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated & Failure to Register and List Not Issued *
September 07, 2012 SR Rosati, Inc. Philadelphia District Office CGMP Regulation For Foods/Adulterated/Misbranded February 28, 2013



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