2008 Warning Letters

Recently Posted | 2011 | 2010 | 2009 | 2008 | 2007 | 2006 | 2005 | 2004 | 2003 | 2002 | 2001 | 2000 | 1999 | 1998 | 1997 | 1996

Warning Letters issued in 2008

 

* 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 April 08, 2009

Letter Issue Date	Company Name	Issuing Office	Subject	Close Out Date
September 05, 2008	White, Rodney A., M.D.	Center for Devices and Radiological Health	Clinical Investigator	N/A *
September 04, 2008	Lifestyle GP Company, LLC	Florida District Office	CGMP/QSR/Medical Devices/Adulterated	N/A *
September 04, 2008	Chloe Foods Corp	New York District Office	Seafood HACCP/GMP for Foods/Adulterated	N/A *
September 04, 2008	Magnificent Medical Equipment, Inc. (dba Tony Riso Company)	Florida District Office	CGMP/QSR/Medical Devices/Adulterated/Misbranded	N/A *
September 03, 2008	Bayer Health Care LLC	Center for Veterinary Medicine	Promotional Claims/False & Misleading/Misbranded	N/A *
September 03, 2008	Gardiziola, Gregory, D.O.	Center for Drug Evaluation and Research	Clinical Investigator	N/A *
September 03, 2008	Shrock, John E.	Cincinnati District Office	Illegal Drug Residue	N/A *
September 03, 2008	Cuisine Solutions, Inc.	Baltimore District Office	Seafood HACCP/Adulterated	N/A *
September 03, 2008	Galveston Shrimp & Fish Company, Inc.	Dallas District Office	Seafood HACCP/CGMP for Foods/Adulterated	N/A *
September 02, 2008	Whitney Labs	Florida District Office	CGMP for Finished Pharmaceuticals/Deviations/Adulterated	N/A *
September 02, 2008	Jerusalem Manufacturing Nature Foods & Wholesalers, Inc.	Detroit District Office	Food Labeling/False & Misleading Claims/Adulterated/Misbranded	N/A *
September 02, 2008	Packers Provisions Co. of PR	San Juan District Office	Seafood HACCP/CGMP for Foods/Adulterated	N/A *
September 02, 2008	Avole, Inc.	San Juan District Office	Seafood HACCP/CGMP for Foods/Adulterated	N/A *
September 02, 2008	Hamilton Medical Center	Center for Devices and Radiological Health	Institutional Review Board (IRB)	N/A *
September 02, 2008	Roselife, LLC	Detroit District Office	CGMP Requirement for Food Manufacturing/Adulterated	N/A *
September 01, 2008	Viacres L.L.L. and Natural Milk L.L.C.	Seattle District Office	Illegal Drug Residue	N/A *
September 01, 2008	Concept Laboratories, Inc.	Chicago District Office	CGMP for Finished Pharmaceuticals/Deviations/Adulterated	N/A *
August 29, 2008	VL Livestock Company, Inc.	Seattle District Office	Illegal Drug Residue	N/A *
August 29, 2008	KeraCure, Inc.	Center for Devices and Radiological Health	Institutional Review Board (IRB)	N/A *
August 28, 2008	Koike Seafood, Inc.	Seattle District Office	Seafood HACCP/CGMP for Foods/Adulterated	N/A *

• Previous
• 1
• 2
• 3
• 4
• 5
• 6
• 7
• 8
• 9
• 10
• 11
• 12
• 13
• 14
• 15
• 16
• 17
• 18
• 19
• 20
• 21
• 22
• Next