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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
09/05/2014 www.mrsnuff.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
09/04/2014 John W Hollis Inc New Orleans District Office Unapproved New Drugs/Misbranded Not Issued *
09/04/2014 Starkist Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated 04/14/2017
09/03/2014 Valeant Pharmaceuticals International New Jersey District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
09/03/2014 Wabash Way Holsteins, LLC Cincinnati District Office Illegal Drug Residue Not Issued *
09/02/2014 Modern Macaroni Co Ltd San Francisco District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
09/02/2014 Aqua, Keith A. M.D. Center for Drug Evaluation and Research Clinical Investigator Not Issued *
08/29/2014 Japanese Specialty Food Distributors Ltd, Co. New England District Office Seafood HACCP/CGMP for Foods/Adulterated 03/11/2015
08/29/2014 Glenville Farms Philadelphia District Office Illegal Drug Residue Not Issued *
08/28/2014 Brava, LLC Center for Devices and Radiological Health Sponsor/Monitor/Contract Research Organization Not Issued *
08/28/2014 CreAgri, Inc. San Francisco District Office New Drug/Labeling/False & Misleading Claims Not Issued *
08/28/2014 Blanc du Blanc, Inc. Florida District Office New Animal Drug/CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
08/28/2014 I'm a Little Teacup Florida District Office New Animal Drug/CGMP/Finished Pharmaceuticals/Adulterated 11/13/2015
08/28/2014 Petaware Florida District Office New Animal Drug/CGMP/Finished Pharmaceuticals/Adulterated/Misbranded Not Issued *
08/28/2014 Charanga Catering, LLC dba Broche 3 Florida District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
08/27/2014 Health Science Products Inc New Orleans District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
08/26/2014 Fleming Laboratories Ltd. Center for Drug Evaluation and Research Generic Drug User Fee Amendments of 2012 (GDUFA) 01/15/2017
08/26/2014 Marck Biosciences Ltd. Center for Drug Evaluation and Research Generic Drug User Fee Amendments of 2012 (GDUFA) Not Issued *
08/26/2014 Microtest Laboratories, Inc. Center for Drug Evaluation and Research Generic Drug User Fee Amendments of 2012 (GDUFA) 09/18/2014
08/26/2014 Ipsi Specialty Foods Kansas City District Office Acidified Foods/Prepared Packed or Held Under Insanitary Conditions 04/22/2015
08/26/2014 M & B Sea Products Inc New England District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 03/04/2015
08/26/2014 OrgSyn Laboratory Inc Center for Drug Evaluation and Research Generic Drug User Fee Amendments of 2012 (GDUFA) Not Issued *
08/26/2014 GE PHARMA LLC New England District Office CGMP/Dietary Supplement/Adulterated/Misbranded Not Issued *
08/26/2014 Andapharm, LLC Center for Drug Evaluation and Research Generic Drug User Fee Amendments of 2012 (GDUFA) 10/10/2014
08/26/2014 Laboratorios Senosiain SA de CV Center for Drug Evaluation and Research Generic Drug User Fee Amendments of 2012 (GDUFA) 03/04/2015
08/25/2014 Ashland Farm, LLC New York District Office Illegal Drug Residue Not Issued *
08/25/2014 Seaview Fisheries Inc. dba Seaview Lobster Co. New England District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 07/27/2017
08/25/2014 www.cigoutlet.biz Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
08/25/2014 www.cigarettesbox.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded 03/10/2016
08/22/2014 Hoover Family Farm Cincinnati District Office Illegal Drug Residue Not Issued *
08/22/2014 Fish Busterz, L.L.C. Florida District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
08/21/2014 Lynn Born Dallas District Office Illegal Drug Residue Not Issued *
08/21/2014 cigarettstore.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
08/21/2014 www.discount-tobacco.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
08/21/2014 G. Wolf Enterprises, Inc. Seattle District Office Acidified Foods/Emergency Permit Control/Seafood HACCP/CGMP/Adulterated/Filth Not Issued *
08/20/2014 Superior Cattle Feeders LLC Los Angeles District Office Illegal Drug Residue Not Issued *
08/19/2014 Meridian Co., Ltd. Center for Devices and Radiological Health Medical Device Reporting/Misbranded Not Issued *
08/19/2014 Descor LLC Baltimore District Office Unapproved New Drugs/Misbranded Not Issued *
08/18/2014 Elite Massagers, LLC Dallas District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
08/18/2014 HUMAN SCIENCE FOUNDATION Los Angeles District Office Unapproved Drugs/Misbranded Not Issued *
08/18/2014 Simply Clean Air & Water Inc. New England District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated 11/05/2015
08/18/2014 Iradimed Corporation Florida District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
08/15/2014 Zions Rx Formulations Services LLC dba Rx Formuations Serv. Los Angeles District Office CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
08/14/2014 Pacific Vision Institute Center for Devices and Radiological Health Medical Device Reporting/Misbranded Not Issued *
08/14/2014 Big Easy Confections, L.L.C. New Orleans District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
08/14/2014 Wickliffe Pharmaceutical Inc Cincinnati District Office Animal Drugs/Adulterated/Misbranded  08/12/2016
08/13/2014 www.primewholesale.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
08/13/2014 www.nefsak.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
08/12/2014 Wise, John M. M.D. Center for Drug Evaluation and Research Clinical Investigator Not Issued *
08/12/2014 The Compounding Shop, Inc. Florida District Office CGMP/Finished Pharmaceuticals/Adulterated Not Issued *

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