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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
04/08/2014 Doughty Valley Holsteins LLC Cincinnati District Office Illegal Drug Residue Not Issued *
04/07/2014 ConAgra Foods Inc Kansas City District Office Food/Prepared/Packed or Held Under Insanitary Conditons/Adulterated 03/24/2015
04/07/2014 www.buyonline-cigarettes.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded 05/29/2014
04/07/2014 Iowa Orchard LLC Kansas City District Office Food/Apple Product/Poisonous or Deleterious Substance Which May Render Injurious to Health 12/16/2014
04/04/2014 East West Distributors Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded 06/03/2014
04/04/2014 Xtra Life Natural Systems, Inc. Florida District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
04/04/2014 Driven Sports Inc. Center for Food Safety and Applied Nutrition Dietary Supplement/Adulterated Not Issued *
04/04/2014 Serpe & Sons Inc Philadelphia District Office CGMP Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated   04/16/2015
04/03/2014 Ed Fields & Sons, Inc Minneapolis District Office Pesticide/Adultered 01/14/2015
04/02/2014 Pure Herbs Ltd Detroit District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
04/02/2014 Graviola Group San Juan District Office Unapproved and Misbranded New Drugs 07/21/2015
04/02/2014 AB Science Center for Veterinary Medicine Unapproved New Animal Drug/Adultered/Misbranded/Misleading Not Issued *
04/01/2014 Cytophil, Inc. Minneapolis District Office CGMP/QSR/Medical Devices/Adulterated 10/24/2014
04/01/2014 LumiQuick Diagnostics Inc. San Francisco District Office CGMP/QSR/Medical Devices/Adulterated 10/19/2015
04/01/2014 Bio-Recovery Inc. Minneapolis District Office CGMP/Dietary Supplement/Adulterated/Misbranded 11/18/2014
03/28/2014 Atom Medical Corporation Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *
03/28/2014 Impladent Ltd. Center for Devices and Radiological Health Sponsor/Monitor/Contract Research Organization 01/05/2016
03/28/2014 North Florida Holsteins, LLC. Florida District Office Illegal Drug Residue Not Issued *
03/28/2014 Instrumed Gmbh Center for Devices and Radiological Health Medical Device Reporting/Adulterated/Misbranding 07/29/2015
03/28/2014 M&A Caribbean Traders, Inc San Juan District Office Unapproved and Misbranded New Drugs 05/08/2014
03/28/2014 Wagner Dairy Operations LLC Minneapolis District Office Illegal Drug Residue 07/23/2014
03/28/2014 Portland Fish Exchange New England District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
03/27/2014 Prismatik Dentalcraft, Inc. Los Angeles District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
03/27/2014 DEWMAR INTERNATIONAL BMC, INC New Orleans District Office Unapproved Food Additive/Nutrient and Health Claims/Adulterated/Misbranded Not Issued *
03/26/2014 All American Coop Minneapolis District Office CGMP/Medicated Feeds/Adulterated 01/05/2015
03/26/2014 P & D Seafood Company Inc Los Angeles District Office Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
03/26/2014 Jernigan Dairy San Francisco District Office Illegal Drug Residue Not Issued *
03/24/2014 Burnette Foods, Inc. Detroit District Office Acidified Foods/Emergency Permit Control/Adulterated/Misbranded 01/22/2015
03/24/2014 Kaiser Air Inc San Francisco District Office PHS Act/Interstate Conveyance Sanitation Not Issued *
03/24/2014 Gulf Shrimp Co. LLC New England District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 03/24/2016
03/21/2014 Shima Laboratories Co., Ltd. Center for Devices and Radiological Health CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated 04/06/2017
03/21/2014 Tang Sang Hah Co., Ltd Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
03/21/2014 www.cigaretteson.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
03/21/2014 Aloe Man International Corp Florida District Office CGMP/Dietary Supplement/Adulterated/Misbranded Not Issued *
03/21/2014 Sandeep Bagla, MD Center for Devices and Radiological Health Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Not Issued *
03/20/2014 Best Choice Trading Corp. New York District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 10/28/2014
03/20/2014 Woodcrest Dairy Llc New York District Office Illegal Drug Residue Not Issued *
03/20/2014 Whole Foods Market Denver Distribution Center Denver District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 11/26/2014
03/19/2014 Monica Farms, LLC New York District Office Illegal Drug Residue Not Issued *
03/19/2014 Bremer, William Minneapolis District Office Illegal Drug Residue 05/16/2014
03/18/2014 Moussa C. Mansour, MD Center for Devices and Radiological Health Clinical Investigator - Human Trials 03/07/2016
03/18/2014 SmithKline Beecham (Cork) Ltd. Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated 08/20/2015
03/17/2014 Ultradent Products, Inc. Denver District Office CGMP/QSR/Medical Devices/Adulterated 11/18/2014
03/17/2014 Branson Baking Co Kansas City District Office CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions Not Issued *
03/17/2014 Jonathan S. Allgyer Minneapolis District Office PHS Act/Shell Egg Regulation/Adulterated 01/13/2015
03/17/2014 E. W. Mailhot Sausage Company New England District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 11/17/2014
03/17/2014 Josephson's Smokehouse Seattle District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
03/14/2014 Dexcom Inc Los Angeles District Office Medical Device Reporting Regulation/Misbranded 05/21/2015
03/14/2014 Pattanam D. Srinivasan, MD Center for Devices and Radiological Health Sponsor-Investigator Not Issued *
03/13/2014 Libi Labs, Inc. Florida District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *

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