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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
December 17, 2004 U R Farms Seattle District Office Extralabel Drug Use in Animals/Adulterated N/A *
December 15, 2004 Roxy Trading, Inc. Los Angeles District Office Seafood HACCP/Adulterated N/A *
December 15, 2004 Kling, Mitchel A., M.D. Center for Devices and Radiological Health Clinical Investigator N/A *
December 15, 2004 White Egret Farm Dallas District Office Control of Communicable Disease N/A *
December 15, 2004 Precision Piece Parts, Inc. Detroit District Office CGMP Requirement of the Quality System Regulation for Medical Devices/Adulterated N/A *
December 15, 2004 Nolan Livestock Minneapolis District Office Extralabel Drug Use in Animals/Adulterated N/A *
December 15, 2004 Parker Foods, LLC Los Angeles District Office Seafood HACCP/Adulterated N/A *
December 15, 2004 Prime Veal Feed, Ltd. Cincinnati District Office Extralabel Drug Use in Animals/Misbranded N/A *
December 14, 2004 Nature's Way Products, Inc. Denver District Office Food/Adulterated N/A *
December 14, 2004 Gourmet Kitchen, Inc. New Jersey District Office CGMP for Foods/Seafood HACCP/Adulterated N/A *
December 14, 2004 TODDS Los Angeles District Office Seafood HACCP/Adulterated N/A *
December 14, 2004 Kinton, Inc. New Jersey District Office Seafood HACCP/Adulterated N/A *
December 14, 2004 Can-x Products Minneapolis District Office Lacks New Drug Approval /Misbranded N/A *
December 10, 2004 Jean's Greens New York District Office Labeling/Promotional Claims False & Misleading/Misbranded N/A *
December 10, 2004 Collins, Tyrone J., M.D. Center for Devices and Radiological Health Clinical Investigator N/A *
December 10, 2004 The Sanapac Co., Inc. Philadelphia District Office Dietary Supplement/Promotional Claims False & Misleading/Adulterated/Misbranded N/A *
December 09, 2004 Lincare, Inc. New Orleans District Office Pharmacy Compounding/Misbranded N/A *
December 09, 2004 Chiron Corporation Office of Enforcement CGMP for Finished Pharmaceuticals/CGMP in Manufacturing, Processing, Packing, or Holding/Adulterated N/A *
December 09, 2004 Sunshine Mills, Inc. New Orleans District Office Animal Proteins Prohibited in Ruminant Feed/Misbranded N/A *
December 09, 2004 Danlee Medical Products, Inc. New York District Office Quality System Regulation for Medical Devices/Adulterated/Misbranded N/A *



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ICECI Warning Letters

Division of Freedom of Information (HFI-35)

Food and Drug Administration

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