• 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

2013 Warning Letters

 
-
Letter Issue Date Company Name Issuing Office Subject Close Out Date
December 31, 2013 John Balbian New York District Office Illegal Drug Residue Not Issued *
December 31, 2013 Buchanan Manufacturing Inc New Orleans District Office Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions January 06, 2015
December 31, 2013 Mapa Gmbh Center for Devices and Radiological Health Medical Device Reporting/Adulterated/Misbranding April 09, 2015
December 31, 2013 Prestige Chinese Teas Company, Inc. San Francisco District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
December 26, 2013 NVN Therapeutics Center for Food Safety and Applied Nutrition Medical Foods/Unapproved New Drug/Misbranded Not Issued *
December 26, 2013 Accera, Inc. Center for Food Safety and Applied Nutrition Medical Foods/Unapproved New Drug/Misbranded Not Issued *
December 20, 2013 Drucker Labs LP Dallas District Office CGMP/Dietary Supplement/Adulterated/Therapeutic Claims Not Issued *
December 20, 2013 Star Scientific, Inc. Center for Food Safety and Applied Nutrition Unapproved and Misbranded New Drugs, Anatabloc and CigRx October 21, 2014
December 20, 2013 www.cheapcigarettes2013.net Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded April 03, 2014
December 20, 2013 Philips Healthcare Los Angeles District Office Medical Device Reporting/Misbranded Not Issued *
December 20, 2013 DNA Genotek Inc. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
December 19, 2013 Three L Farm New York District Office Illegal Drug Residue Not Issued *
December 19, 2013 Baxter Healthcare Corporation Los Angeles District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
December 18, 2013 China Cigarette Manufacture Co., Ltd Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded March 18, 2014
December 18, 2013 www.cigarettesplace.com Center for Tobacco Products Modified Risk Tobacco Products Not Issued *
December 17, 2013 Amplion Clinical Communications Inc New Orleans District Office CGMP/QSR/Medical Devices/Adulterated June 12, 2014
December 17, 2013 Christopher F. Anderson New York District Office Illegal Drug Residue Not Issued *
December 16, 2013 Subcon Manufacturing Corporation Chicago District Office Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) May 05, 2014
December 16, 2013 Quality Beef Company, Inc. New England District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions May 23, 2016
December 13, 2013 Comercial Comtesa S.A. Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
December 13, 2013 G and G Peppers Detroit District Office Low Acid Canned Food Regulation/Adulterated/Insanitary Conditions June 12, 2015
December 13, 2013 PARAYIL FOOD PRODUCTS PVT. LTD. Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
December 13, 2013 Pesquera Alvarez y Alvarez Ltda Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
December 13, 2013 Krier Foods, Inc. Minneapolis District Office CGMP/Dietary Supplement/Adulterated/Misbranded July 18, 2014
December 13, 2013 AFP Advanced Food Products Llc Minneapolis District Office Low Acid Canned Food Regulation/Adulterated June 09, 2014
December 12, 2013 Florida Fertility Institute Florida District Office Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) August 21, 2014
December 12, 2013 SKINREX CO., LTD Center for Devices and Radiological Health Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) Not Issued *
December 12, 2013 Racer Technology Pte Ltd Center for Devices and Radiological Health Quality System Regulation for Medical Devices/Adulterated July 16, 2015
December 12, 2013 Health Breakthrough International, LLC Seattle District Office CGMP/Dietary Supplement/Adulterated/Misbranded Not Issued *
December 12, 2013 DNO Inc Cincinnati District Office CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated Not Issued *
December 11, 2013 Coastal Contacts Inc. Center for Devices and Radiological Health Quality System Regulation/Adulterated/Medical Device Reporting/Misbranded July 16, 2015
December 11, 2013 Dutch-Maid Bakery New Orleans District Office CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions Not Issued *
December 09, 2013 Mayor Laboratories Inc Los Angeles District Office CGMP/Dietary Supplement/Adulterated/Misbranded Not Issued *
December 06, 2013 Eagle New York New Jersey District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions May 02, 2014
December 05, 2013 Green Planet Inc Los Angeles District Office Unapproved and Misbranded New Drugs November 12, 2014
December 05, 2013 Osaki Suisan Co., Ltd. Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
December 04, 2013 Mommy Gina Tuna Resources (MGTR), Inc Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
December 04, 2013 PurQuality, LLC Los Angeles District Office CGMP/Dietary Supplement/Adulterated/Misbranded Not Issued *
December 04, 2013 Rehabtronics Inc. Center for Devices and Radiological Health Quality System Regulation for Medical Devices/Adulterated Not Issued *
December 04, 2013 Hubbard Feeds, Inc. Detroit District Office CGMP/Medicated Feeds/Adulterated January 22, 2015
December 04, 2013 Smith Dairy Cincinnati District Office Illegal Drug Residue Not Issued *
December 04, 2013 Himmelspach, William W. Seattle District Office Illegal Drug Residue Not Issued *
December 03, 2013 Caldwell Animal Hospital New Orleans District Office Illegal Drug Residue Not Issued *
December 03, 2013 Van Erk Dairy LLC Cincinnati District Office Illegal Drug Residue Not Issued *
December 03, 2013 Burzynski Research Institute Center for Drug Evaluation and Research Sponsor/Monitor/Contract Research Organization Not Issued *
December 03, 2013 Burzynski, Stanislaw R. MD Center for Drug Evaluation and Research Clinical Investigator Not Issued *
December 03, 2013 Thang Nguan Hah Co., Ltd. Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
December 02, 2013 Market Technologies Inc. DBA Dermavista New Orleans District Office Medical Device Reporting/Misbranded Not Issued *
December 02, 2013 Ameriderm Laboratories, Ltd. New Jersey District Office CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
November 29, 2013 Velmahos, George C. M.D., Ph.D Center for Biologics Evaluation and Research Clinical Investigator - Human Trials January 03, 2014

-