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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
December 31, 2013 Prestige Chinese Teas Company, Inc. San Francisco District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
December 31, 2013 John Balbian New York District Office Illegal Drug Residue Not Issued *
December 31, 2013 Buchanan Manufacturing Inc New Orleans District Office Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
December 31, 2013 Mapa Gmbh Center for Devices and Radiological Health Medical Device Reporting/Adulterated/Misbranding Not Issued *
December 26, 2013 NVN Therapeutics Center for Food Safety and Applied Nutrition Medical Foods/Unapproved New Drug/Misbranded Not Issued *
December 26, 2013 Accera, Inc. Center for Food Safety and Applied Nutrition Medical Foods/Unapproved New Drug/Misbranded Not Issued *
December 20, 2013 Star Scientific, Inc. Center for Food Safety and Applied Nutrition Unapproved and Misbranded New Drugs, Anatabloc and CigRx Not Issued *
December 20, 2013 DNA Genotek Inc. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
December 20, 2013 Philips Healthcare Los Angeles District Office Medical Device Reporting/Misbranded Not Issued *
December 20, 2013 www.cheapcigarettes2013.net Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded April 03, 2014
December 19, 2013 Three L Farm New York District Office Illegal Drug Residue Not Issued *
December 19, 2013 Baxter Healthcare Corporation Los Angeles District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
December 18, 2013 www.cigarettesplace.com Center for Tobacco Products Modified Risk Tobacco Products Not Issued *
December 18, 2013 China Cigarette Manufacture Co., Ltd Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded March 18, 2014
December 17, 2013 Christopher F. Anderson New York District Office Illegal Drug Residue Not Issued *
December 17, 2013 Amplion Clinical Communications Inc New Orleans District Office CGMP/QSR/Medical Devices/Adulterated June 12, 2014
December 16, 2013 Quality Beef Company, Inc. New England District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
December 16, 2013 Subcon Manufacturing Corporation Chicago District Office Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) May 05, 2014
December 13, 2013 Pesquera Alvarez y Alvarez Ltda Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
December 13, 2013 Krier Foods, Inc. Minneapolis District Office CGMP/Dietary Supplement/Adulterated/Misbranded Not Issued *



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