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 17, 2010
| Letter Issue Date | Company Name | Issuing Office | Subject | Close Out Date |
|---|---|---|---|---|
| August 03, 2010 | Corporacion Del Mar | Center for Food Safety and Applied Nutrition | Seafood HAACP/CGMP for Foods/Adulterated | Not Issued * |
| August 03, 2010 | Baxter International Inc. | Center for Biologics Evaluation and Research | Misleading Efficacy Claim | June 23, 2011 |
| August 02, 2010 | MP Biomedicals LLC | Cincinnati District Office | CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated/Misbranded | Not Issued * |
| August 02, 2010 | Pescamarca | Center for Food Safety and Applied Nutrition | Seafood HACCP/CGMP for Foods/Adulterated | Not Issued * |
| August 02, 2010 | Saputo Cheese USA Inc. | Center for Food Safety and Applied Nutrition | Labeling/False & Misleading Claims/Misbranded | Not Issued * |
| July 30, 2010 | Scully, Sean M.D. | Center for Devices and Radiological Health | Investigational Device Exemptions (Clinical Investigator) | Not Issued * |
| July 30, 2010 | Vaill Brothers | New York District Office | Animals for Sale for Slaughter as Food/Adulterated | Not Issued * |
| July 29, 2010 | Dutch Valley Farms | Denver District Office | Animals for Sale for Slaughter as Food/Adulterated | Not Issued * |
| July 29, 2010 | Golden Pacific Foods Inc. | Los Angeles District Office | Seafood HACCP/Insanitary Conditions/Adulterated/Misbranded | Not Issued * |
| July 29, 2010 | HSMG, Inc. D/b/a Smartinfuser USA | Dallas District Office | Medical Device Reporting Regulation/Misbranded | Not Issued * |
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