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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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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

 
Letter Issue Date Company Name Issuing Office Subject Close Out Date
December 08, 2004 Lamar Seafood Corporation Florida District Office Seafood HACCP/Adulterated N/A *
December 08, 2004 Veterinary Enterprises of Tomorrow, Inc. Dallas District Office Active Pharmaceutical Ingredient/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 California Natural Products San Francisco District Office Low-Acid Foods/Adulterated N/A *
December 06, 2004 Weyand Fisheries, Inc. Detroit District Office Seafood HACCP/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 Purest Colloids, Inc. New Jersey District Office Promotional Claims/False & Misleading/Misbranded N/A *
December 02, 2004 Colloids for Life, LLC Denver District Office Labeling/Promotional Claims False & Misleading/New Drug N/A *
December 01, 2004 Bearden Sandwich Co., Inc. New Orleans District Office Seafood HACCP/Adulterated 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 29, 2004 Novartis Animal Health Services AG Atlanta District Office Adverse Drug Experience Reporting Requirements 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 Thuemmel Dairy, Inc. Detroit District Office Illegal Drug Residue in Animal Tissue/Extralabel Drug Use/Adulterated N/A *
November 23, 2004 Kegelmaster 2000 Ltd. Florida District Office CGMP for Medical Devices/QSR/Adulterated/Misbranded N/A *
November 22, 2004 Miracle Fish, Inc. Florida District Office Seafood HACCP N/A *
November 22, 2004 Moshirfar, Majid, M.D. Center for Devices and Radiological Health Clinical Investigator N/A *
November 22, 2004 Aurora Imaging Technology, Inc. New England District Office Quality System Regulation for Medical Devices/Adulterated N/A *



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ICECI Warning Letters

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