• 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

2012 Warning Letters

Letter Issue Date Company Name Issuing Office Subject Close Out Date
October 10, 2012 Nissei Precision Instruments (Suzhou) Co., Ltd Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
October 10, 2012 Garlic Rx Cincinnati District Office New Drug/Labeling/Misbranded Not Issued *
October 10, 2012 Primus Medical LLC Cincinnati District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated Not Issued *
October 10, 2012 Balin, Martin S., MD, PhD Chicago District Office Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) April 23, 2013
October 10, 2012 Zian Medical, LLC Center for Devices and Radiological Health Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) Not Issued *
October 09, 2012 Country Fresh Orlando, LLC Florida District Office Labeling/False & Misleading Claims/Misbranded July 11, 2013
October 09, 2012 Stat Rx USA Atlanta District Office CGMP/Finished Pharmaceuticals/Adulterated/Misbranded Not Issued *
October 09, 2012 SMT-Schilling Metalltechnik GmbH Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
October 09, 2012 MEDDEV USA, INC. Dallas District Office Medical Devices/Adulterated/Quality System Regulation (QSR) Not Issued *
October 09, 2012 Medical Device Resource Corp San Francisco District Office Premarket Approval/Misbranded/Adulterated Not Issued *
October 05, 2012 Bioque Technology Center for Food Safety and Applied Nutrition New Drug Application [NDA] Not Issued *
October 05, 2012 Tri State Agri Services, LLC Dallas District Office CGMP for Licensed Medicated Feeds/Adulterated Not Issued *
October 05, 2012 Wholistic Herbs, Inc. Dallas District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
October 05, 2012 Food for Health International, LLC Denver District Office CGMP For Manufacturing, Packaging, Labeling, or Holding for Dietary Supplements/Adulterated January 13, 2014
October 05, 2012 Hiossen Inc. Philadelphia District Office CGMP/QSR/Medical Devices/Adulterated November 19, 2013
October 05, 2012 Avon Products, Inc. (U.S. Headquarters) Center for Food Safety and Applied Nutrition New Drug/Misbranded Not Issued *
October 05, 2012 Xiantao Rayxin Medical Products Co. Ltd. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *
October 04, 2012 Raw Deal, Inc New Jersey District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
October 04, 2012 Tropical Seafood New Orleans District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
October 03, 2012 Millington Seafood LLC Baltimore District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions September 19, 2013



-