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 28, 2010
| Letter Issue Date | Company Name | Issuing Office | Subject | Close Out Date |
|---|---|---|---|---|
| July 29, 2010 | M.I. Tech Co Ltd | Center for Devices and Radiological Health | Medical Device Reporting (MDR) Regulation Misbranded/Adulterated | Not Issued * |
| July 28, 2010 | Life Recovery Systems HD, LLC | Center for Devices and Radiological Health | Medical Device/Lacks Premarket Approval/Adulterated/Misbranded | October 07, 2010 |
| July 27, 2010 | Eaton Manufacturing Corporation Dba Eaton Medical | New Orleans District Office | Medical Device Reporting/Misbranded | Not Issued * |
| July 27, 2010 | Biomet, Inc. | Center for Devices and Radiological Health | Premarket Approval/Misbranded/Adulterated | February 10, 2011 |
| July 27, 2010 | Gropoint Seafood Industries Sdn Bhd | Center for Food Safety and Applied Nutrition | Seafood HACCP/Adulterated | Not Issued * |
| July 26, 2010 | Nitrox, Inc. | Seattle District Office | CGMP for Finished Pharmaceuticals/Adulterated/Misbranded | Not Issued * |
| July 22, 2010 | Flowers Baking Company of Villa Rica, LLC | Atlanta District Office | Food Labeling Misbranded | Not Issued * |
| July 22, 2010 | Boca Pharmacal Inc. | Florida District Office | Unapproved New Drug/Misbranded | Not Issued * |
| July 21, 2010 | Stuart Harlin, Md | Center for Devices and Radiological Health | Clinical Investigator | Not Issued * |
| July 21, 2010 | U.F.S. Industries, Inc. (d/b/a) Sally Sherman Foods | New York District Office | Seafood HACCP/CGMP for Foods/Adulterated | January 20, 2011 |
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