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