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 June 22, 2010
Letter Issue Date | Company Name | Issuing Office | Subject | Close Out Date |
---|---|---|---|---|
June 16, 2010 | Oxford Falls | New Orleans District Office | Food Labeling/Misbranded | June 27, 2012 |
June 15, 2010 | Skogen, John L. | Minneapolis District Office | Illegal Drug Residue | November 15, 2010 |
June 15, 2010 | Union Development Frozen Foods Co., Ltd | Center for Food Safety and Applied Nutrition | Seafood HACCP/Adulterated/Misbranded | Not Issued * |
June 14, 2010 | Catalina Offshore Products, Inc | Los Angeles District Office | Seafood HACCP/CGMP for Foods/Adulterated | March 14, 2011 |
June 11, 2010 | Optovue Inc. | San Francisco District Office | CGMP/QSR/Medical Devices/Adulterated/Misbranded | February 23, 2012 |
June 10, 2010 | Medefil Incorporated | Chicago District Office | CGMP/QSR/Medical Devices/Adulterated | Not Issued * |
June 10, 2010 | Nicola Pizza Inc. | Philadelphia District Office | CGMP for Foods/Labeling/Misbranded | Not Issued * |
June 10, 2010 | Libido Edge Labs, Llc | Cincinnati District Office | Unapproved New Drug Promotional Claims/Misbranded | Not Issued * |
June 10, 2010 | Clearview Farms | Cincinnati District Office | Illegal Drug Residue | Not Issued * |
June 09, 2010 | Adamis Pharmaceuticals | Center for Drug Evaluation and Research | Unapproved New Drug/Misbranded | February 15, 2011 |
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