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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

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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
November 22, 2004 LAR Manufacturing, LLC Florida District Office Quality System Regulation for Medical Devices/Adulterated N/A *
November 19, 2004 Jomara Seafood, Inc. Florida District Office Seafood HACCP/Adulterated N/A *
November 19, 2004 Ortek AG Center for Devices and Radiological Health CGMP Requirements for Medical Devices/Quality System Regulations/Adulterated N/A *
November 19, 2004 Pharmachem Laboratories, Inc. New Jersey District Office Dietary Supplement/Labeling/False & Misleading Claims/Misbranded N/A *
November 19, 2004 ATF Fitness Products, Inc. Philadelphia District Office Dietary Supplement/Labeling/Adulterated N/A *
November 19, 2004 Ferndale Laboratories, Inc. Detroit District Office Lacks Approved New Drug Application/Labeling/Misbranded N/A *
November 19, 2004 Protherics, Inc. Center for Biologics Evaluation and Research Promotional Claims/False & Misleading N/A *
November 19, 2004 DiGiorgio Corp. New Jersey District Office Seafood HACCP/Adulterated N/A *
November 19, 2004 Osprey Seafood of California, Inc. San Francisco District Office Seafood HACCP/Adulterated N/A *
November 18, 2004 LA Dorada Coral Gables, Inc. Florida District Office Seafood HACCP N/A *
November 18, 2004 Parrish & Heimbecker Limited Seattle District Office Animal Proteins Prohibited in Ruminant Feed/Adulterated/Misbranded N/A *
November 17, 2004 Constantine, Niel T., Ph.D. Center for Biologics Evaluation and Research Clinical Investigator N/A *
November 17, 2004 Community Hospital & Rehabilitation Center of Los Gatos San Francisco District Office Mammography Quality Standards N/A *
November 17, 2004 Nuclear Cardio Systems, Inc. Denver District Office CGMP Requirement of the Quality System Regulation for Medical Devices/Adulterated N/A *
November 17, 2004 Pajunk GmbH Center for Devices and Radiological Health CGMP for Medical Devices/QSR/Adulterated/Misbranded N/A *
November 17, 2004 Amsterdam, Daniel, Ph.D. Center for Biologics Evaluation and Research Clinical Investigator N/A *
November 16, 2004 MED-EL ELEKTRO-MEDIZINISCHE GERATE GmbH Center for Devices and Radiological Health CGMP Requirement of the Quality System Regulation for Medical Devices/Adulterated N/A *
November 15, 2004 Upscale Foods, Inc. Minneapolis District Office Food Labeling/Misbranded N/A *
November 12, 2004 Clarity, Inc. New Orleans District Office CGMP Requirement of the Quality System Regulation for Medical Devices/Adulterated N/A *
November 10, 2004 Alveolus, Inc. Atlanta District Office CGMP Requirements for Medical Devices/Quality System Regulations/Adulterated N/A *



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ICECI Warning Letters

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