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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 February 23, 2010

Letter Issue Date Company Name Issuing Office Subject Close Out Date
February 12, 2010 LCA Vision Inc/Lasik Plus Vision Center Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded August 16, 2011
February 12, 2010 Lasik Vision Institute Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded Not Issued *
February 11, 2010 Rangen Inc Seattle District Office Animal Proteins Prohibited in Ruminant Feed/Adulterated/Misbranded Not Issued *
February 09, 2010 Lomeo, Simon J. New York District Office Illegal Drug Residue Not Issued *
February 09, 2010 Breckenridge Pharmaceutical, Inc. Florida District Office New Drug/Adulterated Not Issued *
February 09, 2010 P & D Dairy Los Angeles District Office Illegal Drug Residue Not Issued *
February 08, 2010 Poly Pharmaceuticals, Inc New Orleans District Office New Drug/Adulterated Not Issued *
February 08, 2010 Magna Pharmaceuticals, Inc Cincinnati District Office Labeling/False & Misleading Claims/New Drug/Misbranded Not Issued *
February 08, 2010 Jaymac Pharmaceuticals LLC New Orleans District Office New Drug/Adulterated Not Issued *
February 08, 2010 Edwards Pharmaceuticals, Inc New Orleans District Office New Drug/Adulterated Not Issued *
February 05, 2010 Cardiac Science Corporation Seattle District Office CGMP/QSR/Medical Device Reporting/Adulterated/Misbranded Not Issued *
February 05, 2010 Deston Therapeutics, LLC. Atlanta District Office Labeling/New Drug/Misbranded Not Issued *
February 05, 2010 Lilly del Caribe, Inc. (PR05) San Juan District Office CGMP/Active Pharmaceutical Ingredients/Adulterated Not Issued *
February 04, 2010 Summers, Timothy, MD Center for Drug Evaluation and Research Clinical Investigator Not Issued *
February 04, 2010 Kirk Pharmaceuticals, LLC Florida District Office CGMP for Finished Pharmaceuticals/Adulterated Not Issued *
February 04, 2010 Punjwani, Sohail S., M.D. Center for Drug Evaluation and Research Clinical Investigator Not Issued *
February 03, 2010 IPCH Management, Inc Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated Not Issued *
February 03, 2010 Garden-Fresh Foods, Inc. Minneapolis District Office Seafood HACCP Not Issued *
February 02, 2010 Portal Pharmaceutical, Inc. San Juan District Office Labeling/New Drug Application July 06, 2010
February 02, 2010 Societe Nouvelle Averio Maroc Center for Food Safety and Applied Nutrition Seafood 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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