• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

  • Print
  • Share
  • E-mail

2014 Warning Letters

 
-
Letter Issue Date Company Name Issuing Office Subject Close Out Date
December 09, 2014 NYWP Enterprise LLC. Philadelphia District Office CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions May 12, 2015
December 08, 2014 Yandi New York Trading Co Ltd New York District Office Seafood HACCP/CGMP for Foods/Adulterated October 13, 2015
December 08, 2014 Oxysure Systems, Inc. Dallas District Office CGMP/QSR/Medical Devices/Adulterated 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 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 05, 2014 Murmac Farms LLC Philadelphia District Office Illegal Drug Residue December 04, 2015
December 05, 2014 Pacific Hi - Tak Inc San Francisco District Office Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
December 04, 2014 Saint Mary's Medical Group, Inc. San Francisco District Office Mammography Quality Standards Not Issued *
December 04, 2014 DG Farms San Francisco District Office Illegal Drug Residue Not Issued *
December 04, 2014 Maquet Cardiopulmonary Ag Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated April 04, 2016
December 03, 2014 Michael A Hatcher Cincinnati District Office Illegal Drug Residue Not Issued *
November 28, 2014 Remington Medical, S.A. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *
November 28, 2014 Hyland Acres Jerseys, Ltd. Cincinnati District Office Illegal Drug Residue Not Issued *
November 26, 2014 Buffalo Gills LLC Baltimore District Office Acidified Foods/Emergency Permit Control/Adulterated/Misbranded Not Issued *
November 26, 2014 Stanmore Implants Worldwide Ltd. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *
November 25, 2014 Biotest Pharmaceuticals Corp. Office of Regulatory Affairs CGMP/Deviations/Biologics License Application (BLA) Not Issued *
November 25, 2014 Taewoong Medical Co., Ltd. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated September 18, 2015
November 24, 2014 Crimasa Criaderos De Mariscos S. A. Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
November 24, 2014 Cell Vitals Center for Food Safety and Applied Nutrition New Drug/Labeling/Misbranded April 01, 2015

-