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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

Letter Issue Date Company Name Issuing Office Subject Close Out Date
September 21, 2010 Rohr Fish, Inc. Cincinnati District Office Seafood HACCP/Insanitary Conditions/Adulterated Not Issued *
September 21, 2010 Tri-County Food Service & Distribution Inc Cincinnati District Office Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
September 21, 2010 Perma Pure LLC New Jersey District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded October 26, 2011
September 21, 2010 Nature's Health Company, LLC Center for Food Safety and Applied Nutrition Unapproved New Drug/Lacks New Drug Application/Misbranded February 10, 2011
September 20, 2010 Picus, Dr. Joel Center for Drug Evaluation and Research Clinical Investigator Not Issued *
September 17, 2010 Trout Brothers Dairy Philadelphia District Office Animals for Sale for Slaughter as Food/Adulterated Not Issued *
September 16, 2010 Ascension Orthopedics, Inc Dallas District Office Medical Device Reporting(MDR) Regulation Misbranded September 16, 2011
September 15, 2010 Fresenius Medical Care Holdings, Inc. New England District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
September 14, 2010 Actelion Pharmaceuticals U.S., Inc. San Francisco District Office Postmarketing Adverse Drug Experience (PADE) June 13, 2012
September 13, 2010 Nissin Food Co Inc. USA Center for Food Safety and Applied Nutrition Labeling/Misbranded Not Issued *
September 10, 2010 Rico Brand Denver District Office Seafood HACCP/CGMP for Foods/Adulterated August 05, 2011
September 09, 2010 Enriching Gifts International Center for Food Safety and Applied Nutrition Promotional Claims False & Misleading/New Drugs January 13, 2011
September 09, 2010 Neil McIsaac & Son, Inc. San Francisco District Office Animal Sale for Slaughter as Food/Adulterated Not Issued *
September 09, 2010 Bay Regional Medical Center IRB Center for Drug Evaluation and Research Institutional Review Board (IRB) Not Issued *
September 09, 2010 Absolute Packaging, Inc. Florida District Office CGMP for Finished Pharmaceuticals/Adulterated/Misbranded Not Issued *
September 08, 2010 CeraSys, Incorporated Los Angeles District Office Medical Device Reporting (MDR) Regulation Misbranded/Adulterated Not Issued *
September 08, 2010 E-Cig Technology Inc. Center for Drug Evaluation and Research Unapproved New Drug/Misbranded Not Issued *
September 08, 2010 Ruyan America, Inc. Center for Drug Evaluation and Research Unapproved New Drug/Misbranded Not Issued *
September 08, 2010 Penguin Juice Company, Inc. Detroit District Office Juice HACCP Not Issued *
September 08, 2010 Raber View Holstein Cincinnati District Office Illegal Drug Residue December 28, 2011



 

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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