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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

2013 Warning Letters

Letter Issue Date Company Name Issuing Office Subject Close Out Date
January 11, 2013 www.cigaretex.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded 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 11, 2013 Dallas Calco, Inc Dallas District Office CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated Not Issued *
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 Dream Farms Philadelphia District Office Illegal Drug Residue Not Issued *
January 10, 2013 Physicians Total Care, Inc. Dallas District Office CGMP/Finished Pharmaceuticals/Adulterated/Misbranded 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 10, 2013 St Jude Medical CRMD Los Angeles District Office CGMP/QSR/Adulterated/Misbranded Not Issued *
January 09, 2013 Richway NF Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded Not Issued *
January 09, 2013 Mervin Z. Fox Farm Philadelphia District Office Illegal Drug Residue July 09, 2013
January 09, 2013 Curatronic Ltd. Center for Devices and Radiological Health Promotion and Advertising/Misleading/Misbranded Not Issued *
January 09, 2013 Aionex Inc New Orleans District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated Not Issued *
January 07, 2013 Interojo Inc. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated December 16, 2013
January 07, 2013 Canon USA Inc Los Angeles District Office Medical Device Reporting/Misbranded October 23, 2013
January 07, 2013 Usine Rotec Inc Center for Devices and Radiological Health Quality System Regulation/Adulterated/Medical Device Reporting/Misbranded Not Issued *
January 04, 2013 www.smoke-cash.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded March 07, 2014
January 04, 2013 A C Cossor & Son (Surgical) Limited Center for Devices and Radiological Health Quality System Regulation/Adulterated/Medical Device Reporting/Misbranded Not Issued *
January 04, 2013 www.cheap-cig.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded May 29, 2013



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