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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 11, 2014 SUZUKEN CO., LTD. OGUCHI CENTER Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *
June 11, 2014 Smith & Nephew, Inc. Florida District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
June 11, 2014 MANI HANOI CO. LTD Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *
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 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 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 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 Polonica Inc. New Jersey District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
June 04, 2014 Enhancement Medical, LLC Minneapolis District Office CGMP/QSR/Medical Devices/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
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 Antibioticos, S.A. Center for Drug Evaluation and Research Generic Drug User Fee Amendments of 2012 (GDUFA) Not Issued *
May 30, 2014 www.duty-free-goods.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *



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