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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

2013 Warning Letters

Letter Issue Date Company Name Issuing Office Subject Close Out Date
December 03, 2013 Burzynski Research Institute Center for Drug Evaluation and Research Sponsor/Applicant/Monitor/Contract Research Organization Not Issued *
December 03, 2013 Van Erk Dairy LLC Cincinnati District Office Illegal Drug Residue 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 03, 2013 Stanislaw R Burzynski, MD Center for Drug Evaluation and Research Clinical Investigator 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 George C. Velmahos, M.D., Ph.D Center for Biologics Evaluation and Research Bioresearch Monitoring Program/IRB   January 03, 2014
November 27, 2013 Blue Marine Seafood Inc Los Angeles District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
November 27, 2013 Jubilant HollisterStier, LLC Seattle District Office CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
November 27, 2013 www.snusory.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
November 27, 2013 St Vincent Hosp And Hlth Care Center for Drug Evaluation and Research Investigational Review Board (IRB) Not Issued *
November 27, 2013 Vicrossano Inc. Center for Food Safety and Applied Nutrition CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated Not Issued *
November 27, 2013 Blossom Valley Foods Inc San Francisco District Office Acidified Foods/Emergency Permit Control/Adulterated/Misbranded Not Issued *
November 26, 2013 Empacadora Diamante S.A. Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
November 26, 2013 Maple Lane Dairy, Inc. New York District Office Illegal Drug Residue Not Issued *
November 26, 2013 James W. Michalek New York District Office Illegal Drug Residue Not Issued *
November 26, 2013 Verona Veterinary Services, P. C. New York District Office Illegal Drug Residue Not Issued *
November 25, 2013 Johnson Farm LLC New York District Office Illegal Drug Residue Not Issued *
November 25, 2013 Wockhardt Limited Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
November 25, 2013 Sharplight Technologies Center for Devices and Radiological Health CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated Not Issued *



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