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 November 16, 2010
| Letter Issue Date | Company Name | Issuing Office | Subject | Close Out Date |
|---|---|---|---|---|
| November 03, 2010 | Showa Marine Inc | Center for Food Safety and Applied Nutrition | CGMP for Foods/Seafood HACCP/Adulterated | Not Issued * |
| November 03, 2010 | Meiko Food Company Inc. | Los Angeles District Office | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions | September 18, 2012 |
| November 02, 2010 | Dreisbach Enterprises Inc. | San Francisco District Office | Seafood HACCP | Not Issued * |
| November 01, 2010 | Claris Lifesciences Limited | Center for Drug Evaluation and Research | CGMP for Finished Pharmaceutical/Unapproved New Drugs/Adulterated | August 14, 2012 |
| November 01, 2010 | Vitality Products Company Inc. | Philadelphia District Office | Misbranded/Labeling/Unauthorized Health Claims | April 28, 2011 |
| November 01, 2010 | Kashmir Crown Baking LLC | New Jersey District Office | CGMP Regulation For Food/Adulterated | June 09, 2011 |
| November 01, 2010 | Bioenergy, Inc | Minneapolis District Office | Labeling/False & Misleading Claims/Misbranded | August 29, 2011 |
| November 01, 2010 | Hong's Merchandising Group, Inc. | New York District Office | Seafood HACCP/CGMP for Foods/Adulterated | Not Issued * |
| November 01, 2010 | Kashmir Crown Baking LLC | New Jersey District Office | CGMP Regulation For Food/Adulterated | Not Issued * |
| November 01, 2010 | Eckerd Seafood, Inc. | Atlanta District Office | Seafood HACCP | Not Issued * |
| October 29, 2010 | CP Pharmaceuticals, Ltd. | Center for Drug Evaluation and Research | CGMP for Finished Pharmaceuticals/Adulterated | July 23, 2012 |
| October 28, 2010 | Wright Family Dairy | Atlanta District Office | Animals for Sale for Slaughter as Food/Adulterated | Not Issued * |
| October 27, 2010 | Russell C. Davis Planetarium | Center for Devices and Radiological Health | Laser Product Performance Standard | Not Issued * |
| October 27, 2010 | Mexicali Cheese Corp. | New York District Office | CGMP For Manufacturing, Packing, or Holding Human Food/Adulterated | Not Issued * |
| October 26, 2010 | Bay Island, Inc. | Minneapolis District Office | CGMP for Foods/Adulterated | January 31, 2012 |
| October 26, 2010 | Pega Medical Inc. | Center for Devices and Radiological Health | Medical Device Reporting Regulation/Misbranded | Not Issued * |
| October 22, 2010 | Pesnusan Cia Ltda | Center for Food Safety and Applied Nutrition | CGMP for Foods/Seafood HACCP/Adulterated | April 21, 2011 |
| October 21, 2010 | Hong Chang Corporation | Los Angeles District Office | CGMP For Manufacturing, Packing, or Holding Human Food/Adulterated/Insanitary Conditions | Not Issued * |
| October 21, 2010 | Nobel Laboratories, LLC | Dallas District Office | Unapproved New Drug Promotional Claims/Misbranded | Not Issued * |
| October 21, 2010 | Hanover Foods Corporation | Baltimore District Office | CGMP Regulation For Food/Adulterated | Not Issued * |
-
-
