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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
November 07, 2014 Excelsior Medical Corp New Jersey District Office CGMP/QSR/Medical Devices/Adulterated December 07, 2020
November 07, 2014 Nemschoff Chairs, Inc. Minneapolis District Office Medical Device Reporting/Misbranded September 27, 2016
November 06, 2014 Salazones Garre, S.L. Center for Food Safety and Applied Nutrition Food Labeling/Misbranded January 13, 2015
November 06, 2014 Vella Cheese Company of California Inc. San Francisco District Office Low Acid Canned Food Regulation/Adulterated Not Issued *
November 06, 2014 Noel D. Elmore Cincinnati District Office Illegal Drug Residue Not Issued *
November 06, 2014 Topspins, Inc. Detroit District Office CGMP/QSR/Medical Devices/Adulterated January 11, 2017
November 05, 2014 QL FIGO FOODS SDN BHD Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
November 05, 2014 Voss Plastics, Inc. Dallas District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
November 05, 2014 Agrovillaserra, S.L. Center for Food Safety and Applied Nutrition Food Labeling/Misbranded January 13, 2015
November 05, 2014 Valley Foods Inc Cincinnati District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
November 04, 2014 Navilyst Medical, Inc. New York District Office CGMP/QSR/Medical Devices/Adulterated November 25, 2015
November 03, 2014 Sixdog Investments, LLC Denver District Office PHS Act/Shell Egg Regulation/Adulterated Not Issued *
November 03, 2014 Avena Botanicals, Inc. New England District Office CGMP/Dietary Supplement/Adulterated/Misbranded Not Issued *
November 03, 2014 Vietti Acquisitions, LLC New Orleans District Office Low Acid Canned Food Regulation/Adulterated December 15, 2016
November 03, 2014 Van Oriental Food, Inc Dallas District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
October 31, 2014 Nestle Infant Nutrition Center for Food Safety and Applied Nutrition Food Labeling/Misbranded July 13, 2015
October 30, 2014 King Mountain Tobacco Company, Inc. Center for Tobacco Products Interstate Commerce/Tobacco/Adulterated August 02, 2016
October 30, 2014 PI Pharma Inc Cincinnati District Office Unapproved New Drugs/Misbranded Not Issued *
October 30, 2014 VitalHealth Tech Inc. New Jersey District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated May 21, 2015
October 29, 2014 Tri-Star Equine Florida District Office New Animal Drug/Adulterated Not Issued *
October 29, 2014 Ceva Animal Health Pty Ltd Center for Veterinary Medicine New Animal Drug/Adulterated Not Issued *
October 29, 2014 HorsePreRace Florida District Office New Animal Drug/Adulterated Not Issued *
October 29, 2014 International Marine Products, Inc. San Francisco District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
October 29, 2014 Douglas J Gordon Denver District Office New Animal Drug/Adulterated Not Issued *
October 29, 2014 Horse Gold, Inc Florida District Office New Animal Drug/Adulterated Not Issued *
October 29, 2014 Eastern Pharmacy, Inc. Florida District Office Drug/Prepared, Packed or Held Under Insanitary Conditions/Adulterated August 01, 2016
October 29, 2014 Cox Veterinary Laboratory, Inc. Atlanta District Office New Animal Drug/Adulterated Not Issued *
October 29, 2014 MULTIVET USA, Inc. New York District Office New Animal Drug/Adulterated Not Issued *
October 29, 2014 Abler Inc Center for Veterinary Medicine New Animal Drug/Adulterated Not Issued *
October 29, 2014 Generic frontline plus Center for Veterinary Medicine New Animal Drug/Adulterated Not Issued *
October 28, 2014 Xanacare Technologies, LLC Denver District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
October 24, 2014 Helados La Tapatia, Inc San Francisco District Office Food Labeling/Adulterated/Misbranded Not Issued *
October 24, 2014 Pharmagen Laboratories, Inc New England District Office CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
October 23, 2014 PerkinElmer Health Sciences, Inc. Center for Devices and Radiological Health Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device Not Issued *
October 23, 2014 Canine Care Philadelphia District Office New Animal Drug/Adulterated Not Issued *
October 23, 2014 Zhongshan Mei Tung Electronics Ltd. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated/Misbranded October 28, 2015
October 23, 2014 RX South DBA RX3 Compounding Pharmacy LLC Baltimore District Office CGMP/Finished Pharmaceuticals/Adulterated/Misbranded Not Issued *
October 21, 2014 Hikma Farmaceutica, (Portugal) S.A. Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated November 16, 2015
October 21, 2014 DNG Trading & Milling, LLC New York District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
October 17, 2014 Golden Pride, Inc. Florida District Office Unapproved New Drugs/Misbranded Not Issued *
October 17, 2014 Old Mill Bread Company Seattle District Office CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated Not Issued *
October 17, 2014 Vitamins Direct (USA), Inc. Florida District Office Unapproved New Drugs/Misbranded Not Issued *
October 17, 2014 Sekisui Medical Co., Ltd Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated December 20, 2016
October 16, 2014 Dongguan Jianwei Electronics Products Co., Ltd. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *
October 16, 2014 Vitalab Co Inc Kansas City District Office CGMP/Unapproved New Drugs/Dietary Supplements/Adulterated/Misbranding/Labeling August 05, 2015
October 16, 2014 Fitkin Popcorn LLC Kansas City District Office CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated Not Issued *
October 16, 2014 Alopecil Corporation, S.R.L. Center for Food Safety and Applied Nutrition CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
October 15, 2014 Citrus Fit Dallas District Office Unapproved New Drugs/Misbranded Not Issued *
October 15, 2014 Health & Herbs Seattle District Office CGMP/Dietary Supplement/Adulterated/Therapeutic Claims Not Issued *
October 15, 2014 Sharp Global Limited Center for Drug Evaluation and Research CGMP/Active Pharmaceutical Ingredient (API)/Adulterated/Failure to Register February 21, 2017

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