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 March 02, 2010
Letter Issue Date | Company Name | Issuing Office | Subject | Close Out Date |
---|---|---|---|---|
February 17, 2010 | King Cone International | Center for Devices and Radiological Health | Premarket Approval/Misbranded/Adulterated | Not Issued * |
February 16, 2010 | Songkla Canning Public Company Limited | Center for Food Safety and Applied Nutrition | Seafood HACCP | Not Issued * |
February 16, 2010 | La Mexicana, Inc. | Seattle District Office | CGMP For Manufacturing, Packing, or Holding Human Food/Adulterated/Misbranded/Insanitary Conditions | Not Issued * |
February 16, 2010 | Nature'S Gift Inc | Center for Drug Evaluation and Research | Unapproved/Uncleared/Unauthori zed Products Related to the H1N1 Flu Virus | Not Issued * |
February 16, 2010 | Biological Controls | New Jersey District Office | CGMP/QSR/Adulterated/Misbranded | June 15, 2011 |
February 16, 2010 | Gourmet Express Marketing, Inc. | Chicago District Office | Seafood HACCP/CGMP/Misbranded | Not Issued * |
February 16, 2010 | Crestview Calves, Inc. | Seattle District Office | Illegal Drug Residue | Not Issued * |
February 12, 2010 | LASIK Vision Institute LLC | Center for Devices and Radiological Health | Medical Device Reporting Regulation/Misbranded | Not Issued * |
February 12, 2010 | Wu, Helen K. | Center for Devices and Radiological Health | Medical Device Reporting Regulation/Misbranded | July 29, 2011 |
February 12, 2010 | Huyard, Christian M. | Philadelphia District Office | Illegal Drug Residue | Not Issued * |
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