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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

 
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Letter Issue Date Company Name Issuing Office Subject Close Out Date
07/25/2014 William Rausch Cincinnati District Office Illegal Drug Residue Not Issued *
07/25/2014 Mezotrace Corporation San Francisco District Office CGMP/Dietary Supplement/Adulterated Not Issued *
07/25/2014 AMS Health Sciences Dallas District Office Unapproved New Drugs/Misbranded 04/25/2016
07/24/2014 Healthtime dba Deer Garden Foods San Francisco District Office New Drug/Labeling/Misbranded Not Issued *
07/24/2014 Protech Professional Products, Inc. Florida District Office Premarket Approval/Adulterated Not Issued *
07/24/2014 Lao Thai Nam Corporation Dallas District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
07/24/2014 Wabash Cigar Store, Inc. Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded 09/04/2014
07/23/2014 Julian Bakery, Inc. Los Angeles District Office False & Misleading Claims/Misbranded 02/11/2015
07/23/2014 Casa di Pasta, Inc. Baltimore District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 04/15/2015
07/22/2014 H. A. R. Maspeth Corp. New York District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
07/22/2014 K-Fat Inc. New York District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 11/03/2016
07/22/2014 Hoke Farms Philadelphia District Office Illegal Drug Residue 05/08/2015
07/21/2014 Smoker Friendly International LLC Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded 09/19/2014
07/21/2014 Med-Mizer, Inc. Detroit District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
07/18/2014 Calaire Chimie S.A.S. Center for Drug Evaluation and Research Generic Drug User Fee Amendments of 2012 (GDUFA) Not Issued *
07/18/2014 Bioland Technology Ltd. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
07/18/2014 PharMEDium Services, LLC Chicago District Office Compounded Drugs/CGMP Not Issued *
07/18/2014 Contract Coating, Inc. Center for Drug Evaluation and Research Generic Drug User Fee Amendments of 2012 (GDUFA) Not Issued *
07/17/2014 Borinquen Natural, Inc. San Juan District Office New Drug/Misbranded Not Issued *
07/17/2014 PROVITUS Dabrowscy, Malesa S.J. Center for Food Safety and Applied Nutrition Low Acid Canned Food Regulation/Adulterated Not Issued *
07/17/2014 AGRO-SERWIS Center for Food Safety and Applied Nutrition Low Acid Canned Food Regulation/Adulterated Not Issued *
07/17/2014 Klein Laboratories, Inc. New England District Office Unapproved New Drug/Adulterated Not Issued *
07/17/2014 Schindele Enterprises dba Midwest Wholesale Kansas City District Office Unapproved/Misbranded drugs Not Issued *
07/17/2014 Alzohalli, Opada M.D. Center for Drug Evaluation and Research Clinical Investigator Not Issued *
07/17/2014 Baxter Healthcare SA/dba Baxter Healthcare of Puerto Rico San Juan District Office CGMP/QSR/Medical Devices/Adulterated 10/02/2015
07/16/2014 National Cigar Store Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded 10/21/2015
07/15/2014 M.D. Science Lab Florida District Office CGMP/Finished Pharmaceuticals/Adulterated 08/24/2016
07/15/2014 Trivett Sales Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded 09/05/2014
07/15/2014 Graham Shrimp Co., Inc. New Orleans District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
07/15/2014 Yellowstone Tobacco Co, LLC. Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded 10/23/2015
07/15/2014 Dueppengeisser Dairy Company New York District Office Illegal Drug Residue Not Issued *
07/15/2014 Syfrett Feed Co. Florida District Office CGMP/Medicated Feeds/Adulterated Not Issued *
07/15/2014 C P Health Products Inc. New York District Office CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
07/14/2014 Inversiones Peru Pacifico S.A Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
07/14/2014 Marukai Foods Co., Inc. (Takasu Factory) Center for Food Safety and Applied Nutrition CGMP Food/Misbranded 08/20/2014
07/14/2014 Weiner, Gilbert R. Center for Drug Evaluation and Research Clinical Investigator Not Issued *
07/14/2014 Abrams Royal Pharmacy Dallas District Office Compounding Pharmacy/Adulteration/Misbranding 09/28/2016
07/14/2014 Noni Connection dba Puna Noni San Francisco District Office CGMP/Dietary Supplement/Adulterated/Misbranded Not Issued *
07/14/2014 Smoker Friendly Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded 12/10/2014
07/14/2014 RC Compounding Services, LLC Cincinnati District Office Insanitary Conditions/Adulterated Not Issued *
07/10/2014 Black International Enterprise, LLC dba Puba Store Florida District Office Unapproved New Drugs/Misbranded Not Issued *
07/10/2014 Todd & Patty Meech Dairy Farm Minneapolis District Office Illegal Drug Residue Not Issued *
07/10/2014 Diamond W Ranch San Francisco District Office Illegal Drug Residue Not Issued *
07/10/2014 Infopia Co., Ltd. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated 09/14/2015
07/09/2014 Zhejiang Jiuzhou Pharmaceutical Co., Ltd. Center for Drug Evaluation and Research CGMP/Active Pharmaceutical Ingredient (API)/Adulterated 07/05/2016
07/09/2014 www.200cigarettes.biz Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
07/08/2014 Marck Biosciences Ltd. Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
07/08/2014 Atlantic Trading Co. LLC Center for Food Safety and Applied Nutrition Unapproved New Drugs/Misbranded Not Issued *
07/08/2014 Dr. Bronner's Magic Soaps Center for Food Safety and Applied Nutrition Unapproved New Drugs/Misbranded 10/31/2014
07/08/2014 Dr Benedict S Liao Md Los Angeles District Office New Drug/Labeling/False & Misleading Claims Not Issued *

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