2004 Warning Letters

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Warning Letters issued in 2004

 

* 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 May 04, 2009

Letter Issue Date	Company Name	Issuing Office	Subject	Close Out Date
December 08, 2004	Veterinary Enterprises of Tomorrow, Inc.	Dallas District Office	Active Pharmaceutical Ingredient/Adulterated	N/A *
December 08, 2004	Lamar Seafood Corporation	Florida District Office	Seafood HACCP/Adulterated	N/A *
December 08, 2004	Continental Caviar	New Orleans District Office	Seafood HACCP/Adulterated/Misbranded	N/A *
December 07, 2004	Lex, Inc.	Florida District Office	CGMP for Drugs/Manufacture, Processing, Packing, Holding/Adulterated/Misbranded	N/A *
December 07, 2004	Goya Foods, Inc.	New Jersey District Office	Labeling/False & Misleading Claims/Adulterated/Misbranded	N/A *
December 06, 2004	Weyand Fisheries, Inc.	Detroit District Office	Seafood HACCP/Adulterated	N/A *
December 06, 2004	California Natural Products	San Francisco District Office	Low-Acid Foods/Adulterated	N/A *
December 03, 2004	Mind's Eye Juice Company	Seattle District Office	CGMP for Foods/Juice HACCP/Adulterated/Misbranded	N/A *
December 02, 2004	Colloids for Life, LLC	Denver District Office	Labeling/Promotional Claims False & Misleading/New Drug	N/A *
December 02, 2004	Purest Colloids, Inc.	New Jersey District Office	Promotional Claims/False & Misleading/Misbranded	N/A *
December 01, 2004	Bearden Sandwich Co., Inc.	New Orleans District Office	Seafood HACCP/Adulterated	N/A *
November 29, 2004	Novartis Animal Health Services AG	Atlanta District Office	Adverse Drug Experience Reporting Requirements	N/A *
November 29, 2004	Celsis Laboratory Group, St. Louis Division	Center for Drug Evaluation and Research	GLP for Non-Clinical Laboratory Studies	N/A *
November 24, 2004	Berne Hi Way Hatchery, Inc.	Detroit District Office	CGMP for Medicated Feeds/Adulterated	N/A *
November 24, 2004	Sooil Development Co., Ltd	Center for Devices and Radiological Health	CGMP Requirement of the Quality System Regulation for Medical Devices/Adulterated	N/A *
November 23, 2004	Kegelmaster 2000 Ltd.	Florida District Office	CGMP for Medical Devices/QSR/Adulterated/Misbranded	N/A *
November 23, 2004	Thuemmel Dairy, Inc.	Detroit District Office	Illegal Drug Residue in Animal Tissue/Extralabel Drug Use/Adulterated	N/A *
November 22, 2004	Aurora Imaging Technology, Inc.	New England District Office	Quality System Regulation for Medical Devices/Adulterated	N/A *
November 22, 2004	LAR Manufacturing, LLC	Florida District Office	Quality System Regulation for Medical Devices/Adulterated	N/A *
November 22, 2004	Moshirfar, Majid, M.D.	Center for Devices and Radiological Health	Clinical Investigator	N/A *

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