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 April 28, 2010
Letter Issue Date | Company Name | Issuing Office | Subject | Close Out Date |
---|---|---|---|---|
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 * |
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