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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
July 22, 2014 K-Fat Inc. New York District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
July 21, 2014 Med-Mizer, Inc. Detroit District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
July 21, 2014 Smoker Friendly International LLC Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded September 19, 2014
July 18, 2014 Contract Coating, Inc. Center for Drug Evaluation and Research Generic Drug User Fee Amendments of 2012 (GDUFA) Not Issued *
July 18, 2014 PharMEDium Services, LLC Chicago District Office Compounded Drugs/CGMP Not Issued *
July 18, 2014 Calaire Chimie S.A.S. Center for Drug Evaluation and Research Generic Drug User Fee Amendments of 2012 (GDUFA) Not Issued *
July 17, 2014 Opada Alzohalli, M.D. Center for Drug Evaluation and Research Clinical Investigator Not Issued *
July 17, 2014 Schindele Enterprises dba Midwest Wholesale Kansas City District Office Unapproved/Misbranded drugs Not Issued *
July 17, 2014 Klein Laboratories, Inc. New England District Office Unapproved New Drug/Adulterated Not Issued *
July 17, 2014 AGRO-SERWIS Center for Food Safety and Applied Nutrition Low Acid Canned Food Regulation/Adulterated Not Issued *
July 17, 2014 PROVITUS Dabrowscy, Malesa S.J. Center for Food Safety and Applied Nutrition Low Acid Canned Food Regulation/Adulterated Not Issued *
July 16, 2014 National Cigar Store Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
July 15, 2014 Graham Shrimp Co., Inc. New Orleans District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
July 15, 2014 M.D. Science Lab Florida District Office CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
July 15, 2014 Trivett Sales Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded September 05, 2014
July 15, 2014 Yellowstone Tobacco Co, LLC. Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
July 15, 2014 Dueppengeisser Dairy Company New York District Office Illegal Drug Residue Not Issued *
July 15, 2014 Syfrett Feed Co. Florida District Office CGMP/Medicated Feeds/Adulterated Not Issued *
July 15, 2014 C P Health Products Inc. New York District Office CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
July 14, 2014 Smoker Friendly Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *



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