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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
June 28, 2004 Z Cosmetica USA, LLC New York District Office Good Manufacturing Processing, Packing, Holding/Finished Pharmaceuticals/Adulterated N/A *
June 28, 2004 Clinical Diagnostic Solutions Florida District Office Good Manufacturing Practice for Medical Devices Regulation/Quality System/Adulterated N/A *
June 28, 2004 Prime Nutrition Dallas District Office Unapproved New Drug/Adulterated N/A *
June 28, 2004 SmartBodyz Nutrition Dallas District Office Unapproved New Drug/Adulterated N/A *
June 28, 2004 Stellar Seafood and Game, LLP Dallas District Office Seafood HACCP/Adulterated N/A *
June 28, 2004 Affordable Supplements Kansas City District Office Unapproved New Drug/Adulterated N/A *
June 28, 2004 George S. Rogers DBA Marty's Italian Bakery Baltimore District Office GMP for Deviations/Adulterated/Misbranded N/A *
June 28, 2004 Craigador Corporation Minneapolis District Office Food Labeling/Misbranded N/A *
June 28, 2004 GF Health Products, Inc. Denver District Office Quality System/Good Manufacturing Practice/Medical Devices N/A *
June 25, 2004 Nickle, William F. Baltimore District Office Illegal Drug Residue, Animal Tissue/Adulterated N/A *
June 25, 2004 Sunstar Dairy Seattle District Office Illegal Drug Residue in Animal Tissue/Extralabel Drug Use/Adulterated N/A *
June 25, 2004 Three Captains Sea Products, Inc. San Francisco District Office Seafood HACCP/Adulterated N/A *
June 25, 2004 Higher Power, Inc. Seattle District Office Unapproved New Drug/Adulterated N/A *
June 24, 2004 Idacrest Farms, Inc. Seattle District Office Illegal Drug Residue, Animal Tissue/Adulterated N/A *
June 24, 2004 International Groceries, LLC Seattle District Office Seafood HACCP/Adulterated N/A *
June 24, 2004 Everglo-Natural Veterinary Services, Inc. Center for Biologics Evaluation and Research False & Misleading Claims/Misbranded N/A *
June 24, 2004 Million Food Corporation Los Angeles District Office Seafood HACCP/Adulterated N/A *
June 24, 2004 American Sports Nutrition Minneapolis District Office Unapproved New Drug/Adulterated N/A *
June 23, 2004 Loy, Mike Cincinnati District Office Illegal Drug Residue, Animal Tissue/Adulterated/Extra Label Drug Use N/A *
June 23, 2004 C & K Manufacturing & Sales Co., LLC Cincinnati District Office Unapproved New Drug N/A *



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Contact FDA

ICECI Warning Letters

Division of Freedom of Information (HFI-35)

Food and Drug Administration

5600 Fishers Lane

Rockville, MD 20857
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