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 August 31, 2010
Letter Issue Date | Company Name | Issuing Office | Subject | Close Out Date |
---|---|---|---|---|
August 09, 2010 | Village Green Foods, Inc. | Los Angeles District Office | Seafood HACCP/CGMP for Foods/Adulterated | January 10, 2012 |
August 09, 2010 | SNBL USA LTD. | Center for Drug Evaluation and Research | GLP for non-clincal laboratory studies | Not Issued * |
August 05, 2010 | BioVeda | Florida District Office | Premarket Approval/Misbranded/Adulterated | February 10, 2011 |
August 05, 2010 | FACTORIA DEL LAGO C.A. | Center for Food Safety and Applied Nutrition | Seafood HACCP/Adulterated | Not Issued * |
August 05, 2010 | Johnson Sea Products, Inc | New Orleans District Office | Seafood HACCP/CGMP for Foods/Adulterated | Not Issued * |
August 05, 2010 | Madama Oliva Srl | Center for Food Safety and Applied Nutrition | Acidified Foods/Emergency Permit Control/Adulterated/Misbranded | September 14, 2010 |
August 04, 2010 | Sunic's Food, Inc. d.b.a Sun Food Trading Company | Seattle District Office | Seafood HACCP/Adulterated | Not Issued * |
August 04, 2010 | Neoventa Medical AB | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated/Misbranded | Not Issued * |
August 03, 2010 | Cosmed Labs, Inc. | Cincinnati District Office | CGMP for Finished Pharmaceuticals/Adulterated/Misbranded | Not Issued * |
August 03, 2010 | Pioneer Surgical Technology | Center for Devices and Radiological Health | Sponsor/Clinical Investigator | July 17, 2012 |
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