Inspections, Compliance, Enforcement, and Criminal Investigations
-
-
2009 Warning Letters
Recently Posted | 2011 | 2010 | 2009 | 2008 | 2007 | 2006 | 2005 | 2004 | 2003 | 2002 | 2001 | 2000 | 1999 | 1998 | 1997 | 1996
Warning Letters issued in 2009
* 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 November 17, 2009
| Letter Issue Date | Company Name | Issuing Office | Subject | Close Out Date |
|---|---|---|---|---|
| November 09, 2009 | Scotty's, Inc. | Detroit District Office | CGMP Manufacturing, Packing, or Holding Human Food/Adulterated | May 12, 2011 |
| November 09, 2009 | Medtronic Inc. Cardiac Rhythm Disease Managment | Minneapolis District Office | CGMP/QSR/Medical Devices/Adulterated | Not Issued * |
| November 09, 2009 | Provident Pharmaceuticals LLC | Denver District Office | CGMP for Finished Pharmaceuticals/Misbranded/Adulterated | Not Issued * |
| November 09, 2009 | Dallas Jr, Anthony V, MD | Center for Drug Evaluation and Research | Clinical Investigator | Not Issued * |
| November 06, 2009 | Valley Harvest Nut Company | San Francisco District Office | CGMP Regulation For Food/Adulterated | June 22, 2010 |
| November 06, 2009 | Dynamic Nutritional Associates | Seattle District Office | Labeling/False & Misleading Claims/Misbranded | Not Issued * |
| November 06, 2009 | ELA Medical S.A.S. | Center for Devices and Radiological Health | CGMP/QSR/Medical Device Reporting/Misbranded | February 29, 2012 |
| November 06, 2009 | Eisai Medical Research, Inc. | Center for Drug Evaluation and Research | DDMAC/Promotional Claims False & Misleading/Misbranded | Not Issued * |
| November 04, 2009 | Solar Farms, Inc. | Atlanta District Office | CGMP For Human Food, Prepared,Packed, or Held under Insanitary Conditions/Adulterated | Not Issued * |
| November 04, 2009 | Silver Soft for Skin | Center for Drug Evaluation and Research | Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus | Not Issued * |
| November 03, 2009 | Culinaire Incorporated | Denver District Office | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions | Not Issued * |
| November 03, 2009 | Durango Smoke Shop, Inc. | Center for Tobacco Products | Tobacco Products/Adulterated/Misbranded | January 12, 2010 |
| November 03, 2009 | Amsterdam Tobacco Co | Center for Tobacco Products | Tobacco Products/Adulterated/Misbranded | December 02, 2010 |
| November 03, 2009 | Gibson Laboratories Inc | Cincinnati District Office | CGMP for Medical Devices/QS/Adulterated | August 04, 2010 |
| November 03, 2009 | Algisiya Servicesz Limited | Center for Tobacco Products | Tobacco Products/Adulterated | Not Issued * |
| November 03, 2009 | Texas Wholesale | Center for Tobacco Products | Tobacco Products/Adulterated/Misbranded | November 24, 2009 |
| November 03, 2009 | Heavenly Smoke Inc | Center for Tobacco Products | Tobacco Products/Adulterated/Misbranded | December 02, 2010 |
| November 03, 2009 | Chavez, Inc. | Center for Tobacco Products | Tobacco Products/Adulterated/Misbranded | November 24, 2009 |
| November 03, 2009 | Clove Cigarettes Shop | Center for Tobacco Products | Tobacco Products/Adulterated/Misbranded | Not Issued * |
| November 03, 2009 | Euro-Cigs | Center for Tobacco Products | Tobacco Products/Adulterated/Misbranded | Not Issued * |
-
-
