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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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2014 Warning Letters

Letter Issue Date Company Name Issuing Office Subject Close Out Date
June 10, 2014 Tianjin Zhongan Pharmaceutical Co., Ltd. Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
June 09, 2014 Newell Farms Detroit District Office Illegal Drug Residue Not Issued *
June 06, 2014 MTI Precision Products LLC. New Jersey District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
June 06, 2014 Carefusion 2200 Inc Chicago District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
June 06, 2014 Lee and Company Dallas District Office CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
June 06, 2014 www.200cheapcigarettes.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
June 05, 2014 Nutrishop New Jersey District Office Unapproved New Drug/Misbranded Not Issued *
June 05, 2014 www.buy-cheapcigarettes.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
June 05, 2014 www.smokerdirect.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
June 05, 2014 Rod McNeal Dairy Dallas District Office Illegal Drug Residue Not Issued *
June 04, 2014 Enhancement Medical, LLC Minneapolis District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
June 04, 2014 Polonica Inc. New Jersey District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
June 02, 2014 Antibioticos, S.A. Center for Drug Evaluation and Research Generic Drug User Fee Amendments of 2012 (GDUFA) Not Issued *
June 02, 2014 Accelerated Freeze Drying Co. Ltd. Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
June 02, 2014 HeartWare Inc Florida District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
June 02, 2014 American Antibiotics, Inc. Center for Drug Evaluation and Research Generic Drug User Fee Amendments of 2012 (GDUFA) July 23, 2014
May 30, 2014 www.duty-free-goods.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
May 30, 2014 Roundman's Smokehouse San Francisco District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
May 30, 2014 Neurolumen LLC Dallas District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
May 29, 2014 www.cigarette-brands.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *



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