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 October 14, 2010
| Letter Issue Date | Company Name | Issuing Office | Subject | Close Out Date |
|---|---|---|---|---|
| October 12, 2010 | Artery Health Institute LLC | New York District Office | Unapproved New Drugs/Misbranded | Not Issued * |
| October 12, 2010 | World Health Products, Inc. | Denver District Office | Unapproved New Drugs/Misbranded | Not Issued * |
| October 12, 2010 | Maxam Nutraceutics | Seattle District Office | Unapproved New Drugs/Misbranded | Not Issued * |
| October 12, 2010 | Cardio Renew Inc | Minneapolis District Office | Unapproved New Drugs/Misbranded | August 29, 2011 |
| October 08, 2010 | Kanec USA, Inc. | Florida District Office | CGMP for Finished Pharmaceutical/Unapproved New Drugs/Adulterated/Misbranded | Not Issued * |
| October 08, 2010 | Rx-promotion | Center for Drug Evaluation and Research | Internet Marketing of Unapproved and Misbranded Drugs | Not Issued * |
| October 07, 2010 | Biostructures, LLC | Los Angeles District Office | Premarket Approval/Adulterated/Misbranded | December 11, 2012 |
| October 06, 2010 | Thanh Son Tofu Inc | Los Angeles District Office | CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions | Not Issued * |
| October 06, 2010 | Fresh Express Incorporated | San Francisco District Office | False & Misleading Claims/Misbranded | Not Issued * |
| October 05, 2010 | Tropical Bakery Wholesale | Florida District Office | CGMP For Manufacturing, Packing, or Holding Human Food/Adulterated | April 13, 2011 |
| October 05, 2010 | Natural Wellness, LLC | Florida District Office | Unapproved New Drugs/Misbranded | November 07, 2011 |
| October 05, 2010 | Longway Farm | New England District Office | Animals for Sale for Slaughter as Food/Adulterated | October 26, 2010 |
| October 05, 2010 | Zander Scientific, Inc. DBA Zander IVF, Inc. | Florida District Office | CGMP/QSR/Medical Devices/Adulterated/Misbranded | Not Issued * |
| October 04, 2010 | Gold Coast Trading Co. | New York District Office | Seafood HACCP | July 02, 2012 |
| October 01, 2010 | Sepal Reproductive Devices, Inc. | New England District Office | CGMP/QSR/Medical Devices/Adulterated/Misbranded | Not Issued * |
| October 01, 2010 | Brant-Wald Surgicals Inc | New Orleans District Office | CGMP/QSR/Medical Devices/Adulterated/Misbranded | Not Issued * |
| October 01, 2010 | Biotech International | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | Not Issued * |
| September 30, 2010 | Mutual Trading Company Inc | Los Angeles District Office | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions | Not Issued * |
| September 30, 2010 | Choksi Laboratory | Center for Drug Evaluation and Research | CGMP for Finished Pharmaceuticals/Adulterated | Not Issued * |
| September 30, 2010 | DW Trading Inc. | Detroit District Office | CGMP For Manufacturing, Packing, or Holding Human Food/Adulterated | Not Issued * |
-
-
