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 September 14, 2010
| Letter Issue Date | Company Name | Issuing Office | Subject | Close Out Date |
|---|---|---|---|---|
| September 01, 2010 | Cortechs Labs Inc | Los Angeles District Office | CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated | July 18, 2011 |
| August 31, 2010 | iVu Imaging Corporation | Dallas District Office | CGMP/QSR/Adulterated/Manufacture/Packing/Storage/Installation | September 19, 2011 |
| August 30, 2010 | Dr Pepper Snapple Group | Center for Food Safety and Applied Nutrition | False & Misleading Claims/Misbranded | Not Issued * |
| August 30, 2010 | Reddick Dairy | Philadelphia District Office | Animal for Slaughter as Food/Adulterated | Not Issued * |
| August 30, 2010 | Unlimited Nutrition | Atlanta District Office | Dietary Supplement/Labeling/Misbranded | Not Issued * |
| August 30, 2010 | Bristol Myers Squibb Holdings Pharma., Ltd. | San Juan District Office | CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated | June 07, 2011 |
| August 27, 2010 | Matthew N. Songer, MD | Center for Devices and Radiological Health | Investigational Device Exemptions | Not Issued * |
| August 25, 2010 | Sun Pharmaceutical Industries Inc | New Jersey District Office | CGMP for Finished Pharmaceuticals/Adulterated | September 13, 2011 |
| August 25, 2010 | Flagship Niagara League Inc. | Philadelphia District Office | PHS Act/Violation | July 12, 2011 |
| August 25, 2010 | Activa Brand Products, Inc. | Center for Devices and Radiological Health | CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated | Not Issued * |
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