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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 October 07, 2010

Letter Issue Date Company Name Issuing Office Subject Close Out Date
September 30, 2010 O'Barr, Thomas Jr., M.D. Center for Drug Evaluation and Research Clinical Investigator Not Issued *
September 30, 2010 Qualiphar Nv Center for Drug Evaluation and Research CGMP for Finished Pharmaceutical/Adulterated Not Issued *
September 30, 2010 Impact Instrumentation, Inc. New Jersey District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
September 29, 2010 Snow, Lamar L. M.D. Center for Drug Evaluation and Research Clinical Investigator Not Issued *
September 29, 2010 Newberry Farms, LLC Detroit District Office Animal Sale for Slaughter as Food/Adulterated December 10, 2010
September 29, 2010 Kyowa Hakko Kogyo Co., Ltd. Center for Drug Evaluation and Research CGMP for Deviations/Adulterated January 19, 2012
September 28, 2010 St. Jeans Cannery Ltd. Center for Food Safety and Applied Nutrition Deviations From Low Acid Canned Food Regulation/Adulterated Not Issued *
September 28, 2010 Telledant LLC Center for Food Safety and Applied Nutrition Dietary Supplement/Labeling False and Misleading/Misbranded Not Issued *
September 27, 2010 Nexgen Pharma Inc Los Angeles District Office CGMP for Finished Pharmaceutical/Unapproved New Drugs/Adulterated Not Issued *
September 27, 2010 Johnson & Johnson Consumer Group of Companies, Inc. New Jersey District Office New Drug/False Misleading Labeling November 23, 2010


 

Contact FDA

301-796-8490
FDA's Office of Critical Path Programs
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