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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
11/07/2014 Excelsior Medical Corp New Jersey District Office CGMP/QSR/Medical Devices/Adulterated 12/07/2020
11/07/2014 Nemschoff Chairs, Inc. Minneapolis District Office Medical Device Reporting/Misbranded 09/27/2016
11/06/2014 Salazones Garre, S.L. Center for Food Safety and Applied Nutrition Food Labeling/Misbranded 01/13/2015
11/06/2014 Vella Cheese Company of California Inc. San Francisco District Office Low Acid Canned Food Regulation/Adulterated Not Issued *
11/06/2014 Noel D. Elmore Cincinnati District Office Illegal Drug Residue Not Issued *
11/06/2014 Topspins, Inc. Detroit District Office CGMP/QSR/Medical Devices/Adulterated 01/11/2017
11/05/2014 QL FIGO FOODS SDN BHD Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
11/05/2014 Voss Plastics, Inc. Dallas District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
11/05/2014 Agrovillaserra, S.L. Center for Food Safety and Applied Nutrition Food Labeling/Misbranded 01/13/2015
11/05/2014 Valley Foods Inc Cincinnati District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
11/04/2014 Navilyst Medical, Inc. New York District Office CGMP/QSR/Medical Devices/Adulterated 11/25/2015
11/03/2014 Sixdog Investments, LLC Denver District Office PHS Act/Shell Egg Regulation/Adulterated Not Issued *
11/03/2014 Avena Botanicals, Inc. New England District Office CGMP/Dietary Supplement/Adulterated/Misbranded Not Issued *
11/03/2014 Vietti Acquisitions, LLC New Orleans District Office Low Acid Canned Food Regulation/Adulterated 12/15/2016
11/03/2014 Van Oriental Food, Inc Dallas District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
10/31/2014 Nestle Infant Nutrition Center for Food Safety and Applied Nutrition Food Labeling/Misbranded 07/13/2015
10/30/2014 King Mountain Tobacco Company, Inc. Center for Tobacco Products Interstate Commerce/Tobacco/Adulterated 08/02/2016
10/30/2014 PI Pharma Inc Cincinnati District Office Unapproved New Drugs/Misbranded Not Issued *
10/30/2014 VitalHealth Tech Inc. New Jersey District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated 05/21/2015
10/29/2014 Tri-Star Equine Florida District Office New Animal Drug/Adulterated Not Issued *
10/29/2014 Ceva Animal Health Pty Ltd Center for Veterinary Medicine New Animal Drug/Adulterated Not Issued *
10/29/2014 HorsePreRace Florida District Office New Animal Drug/Adulterated Not Issued *
10/29/2014 International Marine Products, Inc. San Francisco District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
10/29/2014 Douglas J Gordon Denver District Office New Animal Drug/Adulterated Not Issued *
10/29/2014 Horse Gold, Inc Florida District Office New Animal Drug/Adulterated Not Issued *
10/29/2014 Eastern Pharmacy, Inc. Florida District Office Drug/Prepared, Packed or Held Under Insanitary Conditions/Adulterated 08/01/2016
10/29/2014 Cox Veterinary Laboratory, Inc. Atlanta District Office New Animal Drug/Adulterated Not Issued *
10/29/2014 MULTIVET USA, Inc. New York District Office New Animal Drug/Adulterated Not Issued *
10/29/2014 Abler Inc Center for Veterinary Medicine New Animal Drug/Adulterated Not Issued *
10/29/2014 Generic frontline plus Center for Veterinary Medicine New Animal Drug/Adulterated Not Issued *
10/28/2014 Xanacare Technologies, LLC Denver District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
10/24/2014 Helados La Tapatia, Inc San Francisco District Office Food Labeling/Adulterated/Misbranded Not Issued *
10/24/2014 Pharmagen Laboratories, Inc New England District Office CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
10/23/2014 PerkinElmer Health Sciences, Inc. Center for Devices and Radiological Health Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device 01/13/2017
10/23/2014 Canine Care Philadelphia District Office New Animal Drug/Adulterated Not Issued *
10/23/2014 Zhongshan Mei Tung Electronics Ltd. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated/Misbranded 10/28/2015
10/23/2014 RX South DBA RX3 Compounding Pharmacy LLC Baltimore District Office CGMP/Finished Pharmaceuticals/Adulterated/Misbranded Not Issued *
10/21/2014 Hikma Farmaceutica, (Portugal) S.A. Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated 11/16/2015
10/21/2014 DNG Trading & Milling, LLC New York District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
10/17/2014 Golden Pride, Inc. Florida District Office Unapproved New Drugs/Misbranded Not Issued *
10/17/2014 Old Mill Bread Company Seattle District Office CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated Not Issued *
10/17/2014 Vitamins Direct (USA), Inc. Florida District Office Unapproved New Drugs/Misbranded Not Issued *
10/17/2014 Sekisui Medical Co., Ltd Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated 12/20/2016
10/16/2014 Dongguan Jianwei Electronics Products Co., Ltd. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *
10/16/2014 Vitalab Co Inc Kansas City District Office CGMP/Unapproved New Drugs/Dietary Supplements/Adulterated/Misbranding/Labeling 08/05/2015
10/16/2014 Fitkin Popcorn LLC Kansas City District Office CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated Not Issued *
10/16/2014 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 *
10/15/2014 Citrus Fit Dallas District Office Unapproved New Drugs/Misbranded Not Issued *
10/15/2014 Health & Herbs Seattle District Office CGMP/Dietary Supplement/Adulterated/Therapeutic Claims Not Issued *
10/15/2014 Sharp Global Limited Center for Drug Evaluation and Research CGMP/Active Pharmaceutical Ingredient (API)/Adulterated/Failure to Register 02/21/2017

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