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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
December 31, 2014 Reeder Farms Detroit District Office Illegal Drug Residue March 13, 2015
December 31, 2014 Flood Brothers, LLC New England District Office Illegal Drug Residue Not Issued *
December 30, 2014 Yamahide Shokuhin, Inc. Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
December 30, 2014 Quality Liquid Feeds, Inc Minneapolis District Office CGMP/Medicated Feeds/Adulterated August 25, 2015
December 29, 2014 MicroAire Surgical Instruments, LLC Baltimore District Office CGMP/QSR/Medical Devices/Adulterated June 13, 2016
December 24, 2014 Shanghai Hua Yue Packaging Products Co., Ltd. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *
December 24, 2014 Nuga Medical Co., Ltd. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *
December 23, 2014 Degania Medical Devices Pvt Ltd. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated March 08, 2016
December 23, 2014 NP Foods Ltd., Starburadze Production Facility Center for Food Safety and Applied Nutrition Food Labeling/Misbranded March 04, 2015
December 23, 2014 Nutri Spec Testing Philadelphia District Office CGMP/Dietary Supplement/Adulterated Not Issued *
December 23, 2014 Nutri Spec Inc Philadelphia District Office CGMP/Dietary Supplement/Adulterated July 17, 2015
December 23, 2014 ECO LLC, DBA ECO Animal Health Center for Veterinary Medicine Unapproved New Animal Drug/Adultered/Misbranded/Misleading Not Issued *
December 23, 2014 Marumi Center for Food Safety and Applied Nutrition Food Labeling/Misbranded February 02, 2015
December 23, 2014 Shoreside Enterprises Inc. Florida District Office Unapproved New Drugs/Misbranded Not Issued *
December 23, 2014 Hageman Dairy Farms Kansas City District Office Illegal Drug Residue January 04, 2016
December 22, 2014 marcigs.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded September 17, 2015
December 19, 2014 Wakai, Ronald, Ph. D. Center for Devices and Radiological Health Investigational Device Exemptions (Clinical Investigator) Not Issued *
December 19, 2014 Reka Health Pte Ltd Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *
December 19, 2014 Rusty Cattle Company Dallas District Office Illegal Drug Residue Not Issued *
December 19, 2014 Novacyl Wuxi Pharmaceutical Co., Ltd. Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Active Pharmaceutical Ingredient(API)/Adulterated Not Issued *
December 18, 2014 Moor Instruments Ltd Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *
December 18, 2014 PreMark Health Science, Inc. Dallas District Office CGMP/Dietary Supplement/Adulterated/Misbranded Not Issued *
December 18, 2014 Wellmill LLC/DBA Vitamix Laboratories New York District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated January 09, 2017
December 18, 2014 Wild Edibles Inc. New York District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
December 18, 2014 Valley Mead Farms LLC Minneapolis District Office Illegal Drug Residue May 19, 2015
December 17, 2014 Dandy Day Corporation Denver District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
December 17, 2014 Padtest, LLC Los Angeles District Office Medical Device Reporting/Misbranded January 26, 2016
December 16, 2014 Masselink Dairy Farm, LLC Detroit District Office Illegal Drug Residue May 15, 2015
December 16, 2014 Little Brown Smoke Shack Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
December 16, 2014 Peter M. Slutzky Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded September 18, 2015
December 16, 2014 Midwest Service & Supply, Inc. Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded September 18, 2015
December 16, 2014 Vivian Juarez Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded September 18, 2015
December 16, 2014 Northerner Scandinavia, Inc. Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
December 16, 2014 William Tisinger Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded September 18, 2015
December 15, 2014 Signal Medical Corporation Detroit District Office Premarket Approval/Adulterated Not Issued *
December 15, 2014 Gerratt Dairy Seattle District Office Illegal Drug Residue Not Issued *
December 12, 2014 Vinyas Innovative Technologies Pvt., Ltd. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
December 11, 2014 Roach's Dairy Farm New York District Office Illegal Drug Residue Not Issued *
December 11, 2014 Biogenix USA, LLC Atlanta District Office CGMP/Dietary Supplement/Adulterated/Misbranded Not Issued *
December 09, 2014 Customed, Inc San Juan District Office CGMP/QSR/Medical Devices/Adulterated December 14, 2016
December 09, 2014 Delta Pharma, Inc. New Orleans District Office CGMP/Drug/Prepared, Packed or Held Under Insanitary Conditions/Adulterated Not Issued *
December 09, 2014 NYWP Enterprise LLC. Philadelphia District Office CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions May 12, 2015
December 09, 2014 Sagemax Bioceramics, Inc. Seattle District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
December 08, 2014 Oxysure Systems, Inc. Dallas District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
December 08, 2014 Emerald Dairy, LLC and Emerald Dairy II, LLC Minneapolis District Office Illegal Drug Residue January 05, 2015
December 08, 2014 Karl Storz Endovision, Inc. New England District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
December 08, 2014 baccycafe.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded September 15, 2015
December 08, 2014 Yandi New York Trading Co Ltd New York District Office Seafood HACCP/CGMP for Foods/Adulterated October 13, 2015
December 05, 2014 Pacific Hi - Tak Inc San Francisco District Office Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
December 05, 2014 Murmac Farms LLC Philadelphia District Office Illegal Drug Residue December 04, 2015

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