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 |
|---|---|---|---|---|
| September 21, 2010 | Tri-County Food Service & Distribution Inc | Cincinnati District Office | Seafood HACCP/CGMP for Foods/Adulterated | Not Issued * |
| September 21, 2010 | Perma Pure LLC | New Jersey District Office | CGMP/QSR/Medical Devices/Adulterated/Misbranded | October 26, 2011 |
| September 21, 2010 | Gilead Sciences Inc | Los Angeles District Office | CGMP for Finished Pharmaceuticals/Adulterated | Not Issued * |
| September 21, 2010 | Nature's Health Company, LLC | Center for Food Safety and Applied Nutrition | Unapproved New Drug/Lacks New Drug Application/Misbranded | February 10, 2011 |
| September 20, 2010 | Picus, Dr. Joel | Center for Drug Evaluation and Research | Clinical Investigator | Not Issued * |
| September 17, 2010 | Trout Brothers Dairy | Philadelphia District Office | Animals for Sale for Slaughter as Food/Adulterated | Not Issued * |
| September 16, 2010 | Ascension Orthopedics, Inc | Dallas District Office | Medical Device Reporting(MDR) Regulation Misbranded | September 16, 2011 |
| September 15, 2010 | Fresenius Medical Care Holdings, Inc. | New England District Office | CGMP/QSR/Medical Devices/Adulterated | Not Issued * |
| September 14, 2010 | Actelion Pharmaceuticals U.S., Inc. | San Francisco District Office | Postmarketing Adverse Drug Experience (PADE) | June 13, 2012 |
| September 13, 2010 | Nissin Food Co Inc. USA | Center for Food Safety and Applied Nutrition | Labeling/Misbranded | Not Issued * |
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