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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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2010 Warning Letters

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Warning Letters issued in 2010

 

* 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

Posted on August 31, 2010

Letter Issue Date Company Name Issuing Office Subject Close Out Date
August 25, 2010 Specialty Brands of America Center for Food Safety and Applied Nutrition Federal Food, Drug and Cosmetic Act/Misbranded Not Issued *
August 24, 2010 18th Street Deli, Inc Detroit District Office Seafood HACCP Not Issued *
August 24, 2010 Storz Medical, AG Center for Devices and Radiological Health CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated Not Issued *
August 23, 2010 Stericon Pharma Pvt. Ltd. Center for Drug Evaluation and Research CGMP for Finished Pharmaceuticals/Adulterated Not Issued *
August 23, 2010 INZ Distributors Inc. / Magic Power Coffee Inc. New York District Office Unapproved New Drug/Misbranded Not Issued *
August 23, 2010 IriSys, Inc. Los Angeles District Office CGMP for Finished Pharmaceuticals/Adulterated/Misbranded September 24, 2012
August 23, 2010 Sallamander Concepts CC Pty Ltd Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated Not Issued *
August 23, 2010 Unilever United States, Inc. Center for Food Safety and Applied Nutrition Promotional Claims False & Misleading/New Drug/Misbranded May 10, 2011
August 20, 2010 The Standing Company Detroit District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
August 20, 2010 Teco Diagnostics Los Angeles District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated Not Issued *
August 19, 2010 B & A Health Products Inc Los Angeles District Office Labeling/OTC Drugs/Misbranded Not Issued *
August 19, 2010 Healex Products Inc. New England District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
August 19, 2010 Depuy Orthopaedics, Inc. Center for Devices and Radiological Health Premarket Approval/Adulterated/Misbranded Not Issued *
August 19, 2010 Peslasa S.A. Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated November 30, 2010
August 18, 2010 MN Airlines LLC dba Sun Country Airlines Los Angeles District Office Interstate Conveyance Sanitation Regulations Not Issued *
August 17, 2010 Ken Corscadden New York District Office Animal Sale for Slaughter as Food/Adulterated Not Issued *
August 17, 2010 AMRI Burlington, Inc. (formerly Hyaluron, Inc.) New England District Office Current Good Manufacturing Practice for Finished Pharmaceuticals/Adulterated Not Issued *
August 16, 2010 R&P Seafood Corp. Los Angeles District Office Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
August 16, 2010 Herman A. Jenkins, M.D. Center for Devices and Radiological Health Premarket Approval Application March 21, 2011
August 13, 2010 Juice Pac Inc Cincinnati District Office Juice/HACCP/Adulterated Not Issued *


 

Contact FDA

FDA's Office of Critical Path and Regulatory Science Initiatives

Frank F. Weichold, MD, PhD

Acting Director

Critical Path and Regulatory Science Initiatives

301-796-8187

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