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 December 28, 2010
| Letter Issue Date | Company Name | Issuing Office | Subject | Close Out Date |
|---|---|---|---|---|
| December 16, 2010 | Synbiotics Ltd | Center for Drug Evaluation and Research | CGMP for Deviations/Adulterated | Not Issued * |
| December 16, 2010 | Karlsburger Foods, Inc. | Minneapolis District Office | CGMP for Foods/Seafood HACCP/Adulterated/Misbranded | October 31, 2011 |
| December 16, 2010 | Mega Sun Inc | Center for Devices and Radiological Health | Electronic Product Radiation Control | Not Issued * |
| December 15, 2010 | NOC Management Co. Inc. | Cincinnati District Office | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions | June 15, 2011 |
| December 15, 2010 | Innovative Medical Manufacturing Co | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | Not Issued * |
| December 15, 2010 | Invacare Corporation | Florida District Office | CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated/Misbranded | Not Issued * |
| December 14, 2010 | Cherokee Brands, LLC | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | February 10, 2011 |
| December 14, 2010 | E.A. Beck & Co. | Los Angeles District Office | CGMP/QSR/Medical Devices/Adulterated/Misbranded | Not Issued * |
| December 13, 2010 | Ray's Seafood Market, Inc. | New England District Office | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions | October 17, 2011 |
| December 10, 2010 | Ian's Natural Foods, Inc | New England District Office | CGMP Regulation For Food/Adulterated | Not Issued * |
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