Inspections, Compliance, Enforcement, and Criminal Investigations
-
-
2010 Warning Letters
Recently Posted | 2011 | 2010 | 2009 | 2008 | 2007 | 2006 | 2005 | 2004 | 2003 | 2002 | 2001 | 2000 | 1999 | 1998 | 1997 | 1996
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 August 17, 2010
| Letter Issue Date | Company Name | Issuing Office | Subject | Close Out Date |
|---|---|---|---|---|
| August 03, 2010 | Corporacion Del Mar | Center for Food Safety and Applied Nutrition | Seafood HAACP/CGMP for Foods/Adulterated | Not Issued * |
| August 03, 2010 | Baxter International Inc. | Center for Biologics Evaluation and Research | Misleading Efficacy Claim | June 23, 2011 |
| August 02, 2010 | MP Biomedicals LLC | Cincinnati District Office | CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated/Misbranded | Not Issued * |
| August 02, 2010 | Pescamarca | Center for Food Safety and Applied Nutrition | Seafood HACCP/CGMP for Foods/Adulterated | Not Issued * |
| August 02, 2010 | Saputo Cheese USA Inc. | Center for Food Safety and Applied Nutrition | Labeling/False & Misleading Claims/Misbranded | Not Issued * |
| July 30, 2010 | Scully, Sean M.D. | Center for Devices and Radiological Health | Investigational Device Exemptions (Clinical Investigator) | Not Issued * |
| July 30, 2010 | Vaill Brothers | New York District Office | Animals for Sale for Slaughter as Food/Adulterated | Not Issued * |
| July 29, 2010 | Dutch Valley Farms | Denver District Office | Animals for Sale for Slaughter as Food/Adulterated | Not Issued * |
| July 29, 2010 | Golden Pacific Foods Inc. | Los Angeles District Office | Seafood HACCP/Insanitary Conditions/Adulterated/Misbranded | Not Issued * |
| July 29, 2010 | HSMG, Inc. D/b/a Smartinfuser USA | Dallas District Office | Medical Device Reporting Regulation/Misbranded | Not Issued * |
| 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 |
-
-
