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

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