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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

Letter Issue Date Company Name Issuing Office Subject Close Out Date
March 21, 2014 www.cigaretteson.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/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 Aloe Man International Corp Florida District Office CGMP/Dietary Supplement/Adulterated/Misbranded Not Issued *
March 20, 2014 Best Choice Trading Corp. New York District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
March 20, 2014 Whole Foods Market Denver Distribution Center Denver District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
March 20, 2014 Woodcrest Dairy 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 19, 2014 Monica Farms, LLC New York District Office Illegal Drug Residue Not Issued *
March 18, 2014 SmithKline Beecham (Cork) Ltd. Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
March 17, 2014 Jonathan S. Allgyer Minneapolis District Office PHS Act/Shell Egg Regulation/Adulterated Not Issued *
March 17, 2014 E. W. Mailhot Sausage Company New England 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 Not Issued *
March 17, 2014 Josephson's Smokehouse Seattle District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
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 Pattanam D. Srinivasan, MD Center for Devices and Radiological Health Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device Not Issued *
March 14, 2014 Dexcom Inc Los Angeles District Office Medical Device Reporting Regulation/Misbranded Not Issued *
March 13, 2014 Libi Labs, Inc. Florida District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
March 12, 2014 Ocean Wave Products, Inc. New York District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
March 11, 2014 Royal Foods Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
March 11, 2014 Teleflex Medical Chicago District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *



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