2008 Warning Letters

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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 June 23, 2009

Letter Issue Date	Company Name	Issuing Office	Subject	Close Out Date
November 13, 2008	Saudek, Christopher D. MD	Center for Devices and Radiological Health	Clinical Investigator	N/A *
November 13, 2008	Artisan Specialty Foods	Chicago District Office	Seafood HACCP	N/A *
November 13, 2008	Rezai, Ali R, M.D	Center for Devices and Radiological Health	Clinical Investigator	N/A *
November 12, 2008	John M. Mellott Farm	Philadelphia District Office	Illegal Drug Residue	N/A *
November 12, 2008	John Mellott Farm	Philadelphia District Office	Illegal Drug Residue	N/A *
November 12, 2008	Steven's Pharmacy	Los Angeles District Office	New Drug/Labeling/False & Misleading Claims	N/A *
November 07, 2008	Hai Soon Leong Sdn Bhd	Center for Food Safety and Applied Nutrition	Seafood HACCP/CGMP for Foods/Adulterated	N/A *
November 04, 2008	Innovative Neurotronic, Inc.	Dallas District Office	CGMP/QSR/Medical Devices/Adulterated	N/A *
November 03, 2008	Blue Ribbon Fish Co.	New York District Office	Seafood HACCP/CGMP for Foods/Adulterated	N/A *
November 03, 2008	Spacelabs Healthcare Incorporated	Seattle District Office	CGMP/QSR/Medical Devices/Adulterated	N/A *
October 31, 2008	Caraco Pharmaceutical Laboratories, Ltd	Detroit District Office	CGMP Deviations	N/A *
October 31, 2008	PrimaPharm Inc.	Los Angeles District Office	Unapproved New Drug/Adulterated/Misbranded	N/A *
October 31, 2008	Three Sister's Snacks Corporation	Minneapolis District Office	Nutrition Labeling of Food/Misbranded	N/A *
October 31, 2008	Deltex Pharmaceuticals Inc	Dallas District Office	CGMP/Otc Drug Products/Adulterated	N/A *
October 29, 2008	Aerosol Science Laboratories Inc.	Center for Drug Evaluation and Research	False & Misleading Claims/New Drug/Misbranded	N/A *
October 28, 2008	BioSafe America Corporation	Los Angeles District Office	CGMP/QSR/Medical Devices/Adulterated/Misbranded	N/A *
October 27, 2008	Bayer HealthCare LLC	Center for Drug Evaluation and Research	Drug Labeling/Promotional Claims/Misbranded	N/A *
October 27, 2008	Bayer HealthCare LLC	Center for Drug Evaluation and Research	Drug Labeling/Promotional Claims/Misbranded	N/A *
October 24, 2008	IBA Molecular, Inc	Baltimore District Office	Deviation/Adulterated	N/A *
October 23, 2008	P East Trading Corporation	New York District Office	Seafood HACCP/Adulterated	N/A *

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