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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
October 20, 2010 Pacific Fishing Company Limited Center for Food Safety and Applied Nutrition CGMP for Foods/Seafood HACCP/Adulterated Not Issued *
October 20, 2010 Axis Health Care LLC New Orleans District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
October 20, 2010 Vita-Herb Nutriceuticals, Inc. Los Angeles District Office CGMP For Manufacturing, Packing, Labeling, or Holding for Dietary Supplements/Adulterated August 29, 2012
October 20, 2010 Lippton, Howard M.D. Center for Drug Evaluation and Research Clinical Investigator Not Issued *
October 20, 2010 Scott, David F., M.D. Center for Drug Evaluation and Research Clinical Investigator Not Issued *
October 18, 2010 Mead Johnson Nutrition Company Detroit District Office Infant Formula/Labeling December 03, 2010
October 15, 2010 Yunnan Hande Bio-Tech. Co. Ltd. Center for Drug Evaluation and Research CGMP For Manufacturing, Packing, or Holding Human Food/Adulterated October 25, 2011
October 15, 2010 Quality Egg LLC Kansas City District Office PHS Act Violation/Adulterated Not Issued *
October 15, 2010 Lighthouse Marina Partnership New Jersey District Office Seafood HACCP November 02, 2012
October 15, 2010 Living Naturally Florida District Office New Drug/Adulterated/Misbranded Not Issued *
October 15, 2010 Prime Time Seafood, Inc Los Angeles District Office Seafood HACCP/CGMP for Foods/Adulterated June 27, 2011
October 14, 2010 Blum's Spring Lake Fisheries Minneapolis District Office Seafood HACCP/CGMP for Foods/Adulterated/Misbranded July 29, 2011
October 14, 2010 Contract Pharmacal Corporation New York District Office CGMP for Finished Pharmaceuticals/Adulterated/Misbranded April 18, 2012
October 14, 2010 Irish Acres Dairy LLC Detroit District Office Animals for Sale for Slaughter as Food/Adulterated February 07, 2011
October 13, 2010 Bos Dairy LLC Detroit District Office Animals for Sale for Slaughter as Food/Adulterated May 09, 2011
October 12, 2010 Dr. Rhonda Henry San Francisco District Office Unapproved New Drugs/Misbranded Not Issued *
October 12, 2010 Evenbetternow, LLC Los Angeles District Office Unapproved New Drugs/Misbranded May 03, 2011
October 12, 2010 Maxam Nutraceutics Seattle District Office Unapproved New Drugs/Misbranded Not Issued *
October 12, 2010 Hormonal Health, LLC Los Angeles District Office Unapproved New Drugs/Misbranded Not Issued *
October 12, 2010 Longevity Plus, LLC Los Angeles District Office Unapproved New Drugs/Misbranded 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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