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 May 25, 2010
| Letter Issue Date | Company Name | Issuing Office | Subject | Close Out Date |
|---|---|---|---|---|
| April 20, 2010 | Milky Way Farm | Atlanta District Office | PHS Act Violation | Not Issued * |
| April 20, 2010 | Capricorn Pharma, Inc. | Baltimore District Office | CGMP for Finished Pharmaceutical/Unapproved New Drugs/Adulterated | March 16, 2011 |
| April 20, 2010 | Rainbow Acres Farm | Philadelphia District Office | PHS Act Violation | Not Issued * |
| April 20, 2010 | Vision Care Holdings, LLC | Center for Devices and Radiological Health | Medical Device Reporting/Misbranded | February 18, 2011 |
| April 20, 2010 | TLC Vision Corporation | Center for Devices and Radiological Health | Medical Device Reporting/Misbranded | February 18, 2011 |
| April 20, 2010 | Lasik Laser | Center for Devices and Radiological Health | Medical Device Reporting/Misbranded | July 29, 2011 |
| April 15, 2010 | Lactasoy Company Limited | Center for Food Safety and Applied Nutrition | Low Acid Canned Food Regulation/Adulterated | Not Issued * |
| April 15, 2010 | Wayne State University IRB | Center for Devices and Radiological Health | Institutional Review Board (IRB) | Not Issued * |
| April 14, 2010 | Lapp, John | Philadelphia District Office | Illegal Drug Residue | Not Issued * |
| April 13, 2010 | Templeton Feed & Grain Inc. | Los Angeles District Office | CGMP for Medicated Feeds/Adulterated | Not Issued * |
| April 13, 2010 | Shreeji Homeo Clinic | Center for Drug Evaluation and Research | Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus | Not Issued * |
| April 13, 2010 | Super Body Care | Center for Drug Evaluation and Research | Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus | Not Issued * |
| April 13, 2010 | Mid South Produce Distributors, LLC | New Orleans District Office | CGMP/Adulterated | November 16, 2010 |
| April 12, 2010 | Hospira, Inc. | Atlanta District Office | CGMP for Finished Pharmaceuticals/Deviations/Adulterated | Not Issued * |
| April 12, 2010 | E-holistic Health /Hanna Cooper | Center for Drug Evaluation and Research | Unapproved/Uncleared/Unauthori zed Products Related to the H1N1 Flu Virus | Not Issued * |
| April 09, 2010 | J & F International, Inc. | Baltimore District Office | Federal Food Drug and Cosmetic Act Violations, Compounded Drugs | December 13, 2010 |
| April 09, 2010 | Pfizer Inc. | Center for Drug Evaluation and Research | Sponsor | Not Issued * |
| April 08, 2010 | Shamrock Medical Solutions Group LLC | New England District Office | CGMP for Finished Pharmaceuticals/Misbranded/Adulterated | Not Issued * |
| April 08, 2010 | Physician Therapeutics, LLC | Los Angeles District Office | New Drug/Labeling/Misbranded/Adulterated | Not Issued * |
| April 08, 2010 | Storz Medical, AG | Center for Devices and Radiological Health | Premarket Approval/Misbranded/Adulterated | Not Issued * |
-
-
