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 December 21, 2010
| Letter Issue Date | Company Name | Issuing Office | Subject | Close Out Date |
|---|---|---|---|---|
| December 06, 2010 | GAR Laboratories Inc | Los Angeles District Office | CGMP/Finished Products/Adulterated | Not Issued * |
| December 06, 2010 | Natural Methods, Inc. | Center for Devices and Radiological Health | Premarket Approval/Adulterated/Misbranded | Not Issued * |
| December 06, 2010 | New Wha Ming Trading of MN, Inc | Minneapolis District Office | CGMP in Manufacturing, Packing, or Holding Human Food/Adulterated | July 08, 2011 |
| December 06, 2010 | Lady-Comp USA | Center for Devices and Radiological Health | Premarket Approval/Misbranded/Adulterated | Not Issued * |
| December 06, 2010 | Valley Electronics GmbH | Center for Devices and Radiological Health | Premarket Approval/Misbranded/Adulterated | Not Issued * |
| December 03, 2010 | Iso-Tex Diagnostics, Inc | Dallas District Office | CGMP for Finished Pharmaceuticals/Adulterated | Not Issued * |
| December 03, 2010 | Hain Celestial Group | Denver District Office | CGMP For Manufacturing, Packing, or Holding Human Food | December 06, 2011 |
| December 02, 2010 | Herbal-supplements-for-you | Center for Food Safety and Applied Nutrition | Labeling/Dietary Supplements/Promotional Claims False & Misleading/Misbranded | Not Issued * |
| December 02, 2010 | LifeNet Health | Center for Devices and Radiological Health | Premarket Approval/Adulterated/Misbranded | Not Issued * |
| December 02, 2010 | Ocean Fresh LLC | San Francisco District Office | Seafood HACCP | November 25, 2011 |
| December 02, 2010 | Nutri Herb Inc | Florida District Office | New Drug/Adulterated/Misbranded | Not Issued * |
| December 02, 2010 | United Taiwan Corp. - Chao Zhou Plant | Center for Food Safety and Applied Nutrition | CGMP for Deviations/Adulterated | May 19, 2011 |
| December 02, 2010 | Prolatis | Denver District Office | Dietary Supplement/Adulterated | Not Issued * |
| December 02, 2010 | Dong-A Otsuka Co. Ltd. | Center for Food Safety and Applied Nutrition | Acidified Foods/Adulterated | March 25, 2011 |
| December 02, 2010 | PCI Synthesis | New England District Office | CGMP For Manfacturing, Processing, Packing, Storage & Holding/Adulterated | September 29, 2011 |
| December 01, 2010 | Advanced Surgical Design & Manufacture, Ltd. | Center for Devices and Radiological Health | CGMP Manufacturer, Processsing, Packing, Holding/Devices/Adulterated | Not Issued * |
| December 01, 2010 | Airgas, Inc. | New Orleans District Office | CGMP for Finished Pharmaceuticals/Adulterated | May 18, 2011 |
| December 01, 2010 | Myron J. Diller Farm | Philadelphia District Office | Animal Sale for Slaughter as Food/Adulterated | Not Issued * |
| November 30, 2010 | OsteoSymbionics LLC | Cincinnati District Office | CGMP/QSR/Medical Devices/Adulterated/Misbranded | Not Issued * |
| November 29, 2010 | Optilasa SA | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | Not Issued * |
-
-
