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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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Tobacco Retailer 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
October 05, 2004 Comercializadors Albino S.A. de C.V. Center for Food Safety and Applied Nutrition Seafood HACCP N/A *
October 04, 2004 Grimmer Enterprises Minneapolis District Office Lacks Approved New Drug Application/Adulterated N/A *
October 04, 2004 Laser Therapeutics, Inc. Center for Devices and Radiological Health Sponsor Obligations N/A *
October 04, 2004 Richards, Jon M., M.D., Ph.D. Center for Biologics Evaluation and Research Clinical Investigator N/A *
October 04, 2004 Shang Gardens, Inc. Minneapolis District Office Food/Adulterated N/A *
September 30, 2004 Parker & Sons, LLC Detroit District Office Illegal Drug Residue, Animal Tissue/Adulterated N/A *
September 30, 2004 United American Industries Los Angeles District Office Food Labeling/Adulterated N/A *
September 30, 2004 Zimmer View Dairy Cincinnati District Office Illegal Drug Residue, Animal Tissue/Adulterated N/A *
September 30, 2004 WNCK, Inc. Dallas District Office CGMP Requirements for Medical Devices/Quality System Regulations/Adulterated N/A *
September 29, 2004 Newman, John H., DVM Dallas District Office Illegal Drug Residue Animal Tissue/Extra-Label Drug Use/Adulterated N/A *
September 29, 2004 F. H. G. Corporation Florida District Office Dietary Supplement/Adulterated N/A *
September 28, 2004 Ideal Optics, Inc. Atlanta District Office Quality System Regulation for Medical Devices/Adulterated N/A *
September 28, 2004 Penner Manufacturing, Inc. Kansas City District Office Quality System Regulation for Medical Devices/Adulterated N/A *
September 28, 2004 Martin, Gene A. Minneapolis District Office Illegal Drug Residue in Animal Tissue/Extralabel Drug Use/Adulterated N/A *
September 28, 2004 Metrotech Medical, Inc. New York District Office Mammography Quality Standards N/A *
September 24, 2004 Supreme Lobster and Seafood Company San Francisco District Office Seafood HACCP/Adulterated N/A *
September 24, 2004 Costa Verde Seafood Distributor San Juan District Office CGMP for Foods/HACCP N/A *
September 24, 2004 C.R. Canfield Co., Inc. Minneapolis District Office Lacks New Drug Application N/A *
September 23, 2004 Holiday Wholesale, Inc. Minneapolis District Office Seafood HACCP/Adulterated N/A *
September 23, 2004 Evercrete International Denver District Office Unapproved New Drugs/Labeling N/A *



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ICECI Warning Letters

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Food and Drug Administration

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