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 October 05, 2010
| Letter Issue Date | Company Name | Issuing Office | Subject | Close Out Date |
|---|---|---|---|---|
| August 13, 2010 | Above Sea Level | Denver District Office | Seafood HACCP/Insanitary Conditions/Adulterated | August 05, 2011 |
| August 13, 2010 | A G Specialty Foods, Inc | Seattle District Office | Seafood HACCP/CGMP for Foods/Adulterated | Not Issued * |
| August 13, 2010 | Inaudi Commerciale Srl | Center for Food Safety and Applied Nutrition | Deviations From Low Acid Canned Food Regulation/Adulterated | Not Issued * |
| August 13, 2010 | Amish Wedding Foods Inc | Cincinnati District Office | Low Acid Canned Food Regulation/Adulterated | March 14, 2011 |
| August 12, 2010 | Summer Infant, Inc. | Center for Devices and Radiological Health | Premarket Approval Application | Not Issued * |
| August 11, 2010 | Shun Fung International Trading Inc. | San Francisco District Office | CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated | Not Issued * |
| August 11, 2010 | Maquet Cardiovascular, LLC | New Jersey District Office | CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated | Not Issued * |
| August 11, 2010 | Emprede S.A. | Center for Food Safety and Applied Nutrition | Seafood HACCP | November 30, 2010 |
| August 10, 2010 | Starion Instruments | San Francisco District Office | Device/Adulterated | June 01, 2011 |
| August 09, 2010 | Diasol Inc | Los Angeles District Office | CGMP/QSR/Medical Devices/Adulterated | Not Issued * |
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