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 April 08, 2009

Letter Issue Date	Company Name	Issuing Office	Subject	Close Out Date
September 25, 2008	Steris Corporation	New England District Office	CGMP/QSR/Medical Devices/Adulterated	N/A *
September 25, 2008	Renewal Research	San Francisco District Office	Promotional Claims False & Misleading Adulterated/Misbranded	N/A *
September 25, 2008	Mallinckrodt Inc.	Center for Drug Evaluation and Research	DDMAC/Promotional Claims False & Misleading/Misbranded	N/A *
September 25, 2008	Johnson & Johnson Pharmaceutical Research and Development, L.L.C.	Center for Drug Evaluation and Research	DDMAC/Promotional Claims False & Misleading/Misbranded	N/A *
September 25, 2008	Forest Laboratories Inc.	Center for Drug Evaluation and Research	DDMAC/Promotional Claims False & Misleading/Misbranded	N/A *
September 24, 2008	Fulton Seafood Inc	Dallas District Office	Seafood HACCP/Adulterated	N/A *
September 24, 2008	C Change Surgical, LLC	Atlanta District Office	CGMP/QSR/Medical Devices/Adulterated	N/A *
September 23, 2008	Pharmalucence, Inc.	New England District Office	CGMP for Finished Pharmaceuticals/Deviations/Adulterated	N/A *
September 19, 2008	Meek's Seafood, Inc.	New Orleans District Office	Seafood HACCP/CGMP for Foods/Adulterated	N/A *
September 18, 2008	Swiss American Products, Inc.	Dallas District Office	CGMP/QSR/Medical Devices/Adulterated	N/A *
September 17, 2008	Technomed Europe	Center for Devices and Radiological Health	CGMP/QSR/Medical Devices/Adulterated	N/A *
September 17, 2008	Omega Supply	Los Angeles District Office	New Drug/Labeling/False & Misleading Claims	N/A *
September 16, 2008	Ranbaxy Laboratories, Ltd., Paonta Sahib, India	Center for Drug Evaluation and Research	CGMP/Drug/Deviations/Adulterated	N/A *
September 16, 2008	Ranbaxy Laboratories, Ltd., Dewas, India	Center for Drug Evaluation and Research	CGMP/Drug/Deviations/Adulterated	N/A *
September 15, 2008	Airsep Corporation	New York District Office	CGMP/QSR/Medical Devices/Adulterated/Misbranded	N/A *
September 11, 2008	A1 Discount Vitamins	Dallas District Office	DDMAC/Promotional Claims False & Misleading/Misbranded	N/A *
September 10, 2008	San Mar Manufacturing Corporation	San Juan District Office	Food Labeling/False & Misleading Claims/Misbranded	N/A *
September 10, 2008	Stratec Medizintechnik Gmbh	Center for Devices and Radiological Health	CGMP/QSR/Medical Devices/Adulterated	N/A *
September 05, 2008	Biosafe Laboratories	Chicago District Office	CGMP/QSR/Medical Devices/Adulterated	N/A *
September 05, 2008	Drs. Foster and Smith, Inc.	Minneapolis District Office	New Animal Drug/Adulterated	N/A *
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 *
August 28, 2008	LSG Sky Chefs	New England District Office	Seafood HACCP/CGMP for Foods/Adulterated	N/A *
August 27, 2008	Sgarlato Laboratories	San Francisco District Office	CGMP/QSR/Medical Devices/Adulterated	N/A *
August 27, 2008	Ziran, Bruce H., MD	Center for Devices and Radiological Health	Clinical Investigator	N/A *
August 27, 2008	Fall Prevention Technologies	Cincinnati District Office	CGMP/QSR/Medical Devices/Adulterated	N/A *
August 25, 2008	A. Tarantino and Sons, Inc.	San Francisco District Office	Seafood HACCP/CGMP for Foods/Adulterated	N/A *
August 25, 2008	Ovation Pharmaceuticals, Inc.	Center for Biologics Evaluation and Research	Promotional Claims/False & Misleading/Misbranded	N/A *
August 22, 2008	Health Center for Better Living, Inc.	Florida District Office	New Drug/Labeling/False & Misleading Claims	N/A *
August 21, 2008	SeniorLife Health Inc.	Los Angeles District Office	New Drug/Labeling/False & Misleading Claims	N/A *
August 21, 2008	Brede, Inc.	Detroit District Office	CGMP/Deviations For Food Manufacturers/Adulterated	N/A *
August 21, 2008	SeniorLife Health Inc.	Los Angeles District Office	New Drug/Misbranded	N/A *

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