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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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2013 Warning Letters

Letter Issue Date Company Name Issuing Office Subject Close Out Date
January 15, 2013 Paul Bianchi, Inc. San Francisco District Office New Animal Drug/Adulterated Not Issued *
January 14, 2013 Woo Young Medical Center for Devices and Radiological Health Medical Devices/Adulterated/Quality System Regulation(QSR) Not Issued *
January 14, 2013 Pinsky Mark, MD Center for Devices and Radiological Health Medical Devices/Institutional Review Board (IRB) Not Issued *
January 14, 2013 Michael Ring, MD Center for Devices and Radiological Health Medical Devices/Institutional Review Board (IRB) Not Issued *
January 11, 2013 www.cigaretex.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
January 11, 2013 Dallas Calco, Inc Dallas District Office CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated Not Issued *
January 11, 2013 Sunburst Trout Company, LLC Atlanta District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
January 11, 2013 True Taste, LLC. Minneapolis District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions August 09, 2013
January 10, 2013 Wexford Labs Inc Kansas City District Office Device/CGMP/QSR Not Issued *
January 10, 2013 Pierino Frozen Foods, Inc. Detroit District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions September 16, 2013
January 10, 2013 St Jude Medical CRMD Los Angeles District Office CGMP/QSR/Adulterated/Misbranded June 30, 2014
January 10, 2013 Physicians Total Care, Inc. Dallas District Office CGMP/Finished Pharmaceuticals/Adulterated/Misbranded Not Issued *
January 10, 2013 Dream Farms Philadelphia District Office Illegal Drug Residue Not Issued *
January 10, 2013 Consolidated Marketing Unlimited, Inc. Florida District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
January 09, 2013 Curatronic Ltd. Center for Devices and Radiological Health Promotion and Advertising/Misleading/Misbranded Not Issued *
January 09, 2013 Mervin Z. Fox Farm Philadelphia District Office Illegal Drug Residue July 09, 2013
January 09, 2013 Aionex Inc New Orleans District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated August 01, 2014
January 09, 2013 Richway NF Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded Not Issued *
January 07, 2013 Interojo Inc. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated December 16, 2013
January 07, 2013 Usine Rotec Inc Center for Devices and Radiological Health Quality System Regulation/Adulterated/Medical Device Reporting/Misbranded Not Issued *



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