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 March 08, 2011
| Letter Issue Date | Company Name | Issuing Office | Subject | Close Out Date |
|---|---|---|---|---|
| December 10, 2010 | Naturally For Her | Center for Devices and Radiological Health | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) | Not Issued * |
| December 10, 2010 | Macco Organiques | Center for Drug Evaluation and Research | CGMP for Deviations/Adulterated | Not Issued * |
| December 09, 2010 | American Seafood Company Inc | New Orleans District Office | CGMP for Foods/Seafood HACCP/Adulterated | Not Issued * |
| December 09, 2010 | Yuki Gosei Kogyo Co., Ltd. | Center for Drug Evaluation and Research | CGMP for Deviations/Adulterated | Not Issued * |
| December 09, 2010 | New Life Alternatives | New Orleans District Office | Dietary Supplements | Not Issued * |
| December 07, 2010 | Copper River Seafoods, Inc. | Seattle District Office | CGMP for Foods/Seafood HACCP/Adulterated &Low Acid Canned Food Regulation | Not Issued * |
| December 07, 2010 | VBM Medizintechnik GmbH | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated/Misbranded | Not Issued * |
| December 07, 2010 | BioCheck Inc | San Francisco District Office | Premarket Approval/Adulterated/Misbranded | February 16, 2011 |
| December 07, 2010 | Profit & Loss Dairy | Dallas District Office | Animals for Sale for Slaughter as Food/Adulterated | Not Issued * |
| December 07, 2010 | Newman's Fish Markets, Inc. | Seattle District Office | Seafood HACCP/CGMP for Foods/Adulterated | Not Issued * |
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