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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 30, 2010 Impact Instrumentation, Inc. New Jersey District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded January 09, 2013
September 30, 2010 Qualiphar Nv Center for Drug Evaluation and Research CGMP for Finished Pharmaceutical/Adulterated Not Issued *
September 30, 2010 DW Trading Inc. Detroit District Office CGMP For Manufacturing, Packing, or Holding Human Food/Adulterated 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 29, 2010 Snow, Lamar L. M.D. Center for Drug Evaluation and Research Clinical Investigator Not Issued *
September 28, 2010 Telledant LLC Center for Food Safety and Applied Nutrition Dietary Supplement/Labeling False and Misleading/Misbranded Not Issued *
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 27, 2010 Nexgen Pharma Inc Los Angeles District Office CGMP for Finished Pharmaceutical/Unapproved New Drugs/Adulterated March 06, 2013
September 27, 2010 Steris Isomedix Services, Inc. Dallas District Office CGMP/QSR/Medical Devices/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
September 27, 2010 Walgreen Company Chicago District Office New Drug/False Misleading Labeling March 21, 2011
September 27, 2010 CVS Pharmacy, Inc. New England District Office New Drug/False Misleading Labeling December 21, 2010
September 24, 2010 Kranenburg Dairy Dallas District Office Illegal Drug Residue Not Issued *
September 24, 2010 Rohrer Dairy Farms Llc Philadelphia District Office Illegal Drug Residue Not Issued *
September 23, 2010 Mundt & Associates, Inc. Center for Devices and Radiological Health Electronic Product Radiation Control December 15, 2010
September 22, 2010 Defibtech, LLC New England District Office CGMP/QSR/Medical Devices/Adulterated February 02, 2012
September 22, 2010 Spineology, Inc. Center for Devices and Radiological Health Investigational Device Exemptions June 28, 2012
September 22, 2010 Quality Plus Products, Inc. Seattle District Office Seafood HACCP/Adulterated Not Issued *
September 21, 2010 Gilead Sciences Inc Los Angeles District Office CGMP for Finished Pharmaceuticals/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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