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