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 July 08, 2009

Letter Issue Date	Company Name	Issuing Office	Subject	Close Out Date
October 09, 2008	Legacy Dairy Farms LP	Dallas District Office	Illegal Drug Residue	N/A *
October 09, 2008	Richards, Douglas L.	New York District Office	Illegal Drug Residue	N/A *
October 09, 2008	Jarrett Fertility Group, LLC	Detroit District Office	Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products	N/A *
October 09, 2008	Center for Fertility and Gynecology	Los Angeles District Office	Human Cells, Tissues & Cellular Products	N/A *
October 08, 2008	Mackinac Straits Fish Company, inc.	Detroit District Office	Seafood HACCP/CGMP for Foods/Adulterated	N/A *
October 08, 2008	Organizaciion Agricultores Bo. Espino	San Juan District Office	Seafood HACCP/CGMP for Foods/Adulterated	N/A *
October 08, 2008	Citra Mina Seafood Corporation	Center for Food Safety and Applied Nutrition	Seafood HACCP/Adulterated	N/A *
October 07, 2008	F.B. Indian Ridge Dairy	Dallas District Office	Illegal Drug Residue	N/A *
October 07, 2008	Town of Bucksport	New England District Office	PHS Act/Violation	N/A *
October 06, 2008	Lisanby, Sarah H., M.D.	Center for Devices and Radiological Health	Clinical Investigator	N/A *
October 02, 2008	Madespa S.A.	Center for Devices and Radiological Health	CGMP Requirements for Medical Devices/Quality System Regulations/Adulterated	N/A *
October 01, 2008	Holub, Richard, MD	Center for Drug Evaluation and Research	Clinical Investigator	N/A *
September 30, 2008	Neuro Kinetics, Inc.	Philadelphia District Office	Premarket Approval/Misbranded/Adulterated	N/A *
September 30, 2008	Pure Prescriptions Inc.	Los Angeles District Office	New Drugs	N/A *
September 30, 2008	Wellmont Holston Valley Medical Center	Center for Devices and Radiological Health	Institutional Review Board (IRB)	N/A *
September 29, 2008	Laboratory Corporation of America	Center for Devices and Radiological Health	Device Lacks Marketing Clearance Approval/Adulterated/Misbranded	N/A *
September 29, 2008	Lehman's Egg Service Inc.	Philadelphia District Office	Acidified Foods/Emergency Permit Control/Adulterated/Misbranded	N/A *
September 26, 2008	Alpine Oral Care, LLC	Dallas District Office	CGMP/QSR/Medical Devices/Adulterated/Misbranded	N/A *
September 25, 2008	Novartis Pharmaceuticals Corp	Center for Drug Evaluation and Research	DDMAC/Promotional Claims False & Misleading/Misbranded	N/A *
September 25, 2008	Trident Seafoods, Inc.	Seattle District Office	Seafood HACCP/GMP for Foods/Adulterated	N/A *

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