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 August 31, 2010
Letter Issue Date | Company Name | Issuing Office | Subject | Close Out Date |
---|---|---|---|---|
August 25, 2010 | Specialty Brands of America | Center for Food Safety and Applied Nutrition | Federal Food, Drug and Cosmetic Act/Misbranded | Not Issued * |
August 24, 2010 | 18th Street Deli, Inc | Detroit District Office | Seafood HACCP | Not Issued * |
August 24, 2010 | Storz Medical, AG | Center for Devices and Radiological Health | CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated | Not Issued * |
August 23, 2010 | Stericon Pharma Pvt. Ltd. | Center for Drug Evaluation and Research | CGMP for Finished Pharmaceuticals/Adulterated | Not Issued * |
August 23, 2010 | INZ Distributors Inc. / Magic Power Coffee Inc. | New York District Office | Unapproved New Drug/Misbranded | Not Issued * |
August 23, 2010 | IriSys, Inc. | Los Angeles District Office | CGMP for Finished Pharmaceuticals/Adulterated/Misbranded | Not Issued * |
August 23, 2010 | Sallamander Concepts CC Pty Ltd | Center for Devices and Radiological Health | Premarket Approval/Misbranded/Adulterated | Not Issued * |
August 23, 2010 | Unilever United States, Inc. | Center for Food Safety and Applied Nutrition | Promotional Claims False & Misleading/New Drug/Misbranded | May 10, 2011 |
August 20, 2010 | The Standing Company | Detroit District Office | CGMP/QSR/Medical Devices/Adulterated/Misbranded | Not Issued * |
August 20, 2010 | Teco Diagnostics | Los Angeles District Office | CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated | Not Issued * |
- Previous
- 1
- 2
- 3
- 4
- 5
- 6
- 7
- 8
- 9
- 10
- 11
- 12
- 13
- 14
- 15
- 16
- 17
- 18
- 19
- 20
- 21
- 22
- 23
- 24
- 25
- 26
- 27
- 28
- 29
- 30
- 31
- 32
- 33
- 34
- 35
- 36
- 37
- 38
- 39
- 40
- 41
- 42
- 43
- 44
- 45
- 46
- 47
- 48
- 49
- 50
- 51
- 52
- 53
- 54
- 55
- 56
- 57
- 58
- 59
- 60
- 61
- 62
- Next
-
-