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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

2011 Warning Letters

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Warning Letters issued in 2011

 

* Not issued: A close-out letter may issue when, based on FDA’s evaluation, the firm has taken corrective action to address the violations contained in the Warning Letter. This procedure applies to Warning Letters issued on or after September 1, 2009.

* N/A: Not applicable, the Warning Letter was issued prior to September 1, 2009.

Read more about warning and close-out letters

Letter Issue Date Company Name Issuing Office Subject Close Out Date
October 17, 2011 Gro-Lan Farms Philadelphia District Office Illegal Drug Residue November 21, 2013
October 14, 2011 Teasley, Laura A., M.D. Center for Drug Evaluation and Research Clinical Investigator Not Issued *
October 13, 2011 True World Foods Chicago LLC Chicago District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions March 13, 2013
October 13, 2011 United Prosperity Group DBA The Produce Company San Francisco District Office CGMP for Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions June 27, 2012
October 13, 2011 Rocket Medical Plc Center for Devices and Radiological Health Adultered Device/Quality Control Not Issued *
October 13, 2011 Jansen’s Sweet Sinsations, Inc. Cincinnati District Office CGMP Food/Adulterated/Misbranded May 30, 2012
October 13, 2011 Testing Center of Sanitation & Environment Technic Institute Center for Devices and Radiological Health Adulterated Device/Misbranding January 31, 2014
October 13, 2011 Mylan LLC. San Juan District Office CGMP for Finished Pharmaceuticals/Adulterated June 07, 2013
October 12, 2011 Measurement Specialties, Inc. Cincinnati District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
October 12, 2011 Topcon Corporation Center for Devices and Radiological Health Medical Devices/Adulterated/No PMA Not Issued *
October 11, 2011 Bob Osborn Detroit District Office Illegal Drug Residue October 01, 2012
October 11, 2011 Jazz Pharmaceuticals, Inc San Francisco District Office Postmarketing Adverse Drug Experience Reporting Requirements August 02, 2013
October 11, 2011 National Therapy Products, Inc. Center for Devices and Radiological Health Medical Device/Misbranded/MDR Not Issued *
October 11, 2011 Nordimex, LLC Los Angeles District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
October 11, 2011 Respironics, Inc. Philadelphia District Office Device/Adulterated April 12, 2012
October 11, 2011 Hong Kong Food Co. Los Angeles District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
October 07, 2011 Sunshine Dairy Detroit District Office Illegal Drug Residue February 15, 2012
October 07, 2011 SmithKline Beecham Limited Center for Drug Evaluation and Research Finished Pharmaceuticals/Adulterated March 20, 2013
October 06, 2011 Eastern Treats Specialty Foods, Inc. Florida District Office CGMP Regulation For Food/Adulterated April 16, 2012
October 05, 2011 Island Desserts LLC New England District Office CGMP for Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions July 13, 2012



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