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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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2003 Warning Letters

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Warning Letters issued in 2003

 

* 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
February 13, 2003 Fresh Creative Foods Los Angeles District Office Seafood HACCP/Adulterated N/A *
February 12, 2003 FCH Enterprises Inc. San Francisco District Office Food Labeling/Misbranded N/A *
February 10, 2003 PureTek Corporation Los Angeles District Office CGMP in Manufacturing, Processing, Packing or Holding/CGMP for Finished Pharmaceuticals/Adulterated N/A *
February 06, 2003 Eon Labs, Inc. New York District Office CGMP in Manufacturing, Processing, Packing or Holding/CGMP for Finished Pharmaceuticals/Adulterated N/A *
February 06, 2003 MAK-SYSTEM S.A. International Group Center for Biologics Evaluation and Research Quality System Regulation/Adulterated N/A *
February 06, 2003 Echeverria Dairy Los Angeles District Office Edible Tissue/Adulterated N/A *
February 06, 2003 American Analytical Chemistry Laboratories, Ltd. Chicago District Office CGMP for Finished Pharmaceuticals/Adulterated N/A *
February 05, 2003 Master Industries, LLC Los Angeles District Office QSR/Lacks Premarket Approval Application/Adulterated/Misbranded N/A *
February 05, 2003 Springhill Memorial Hospital New Orleans District Office Mammography Quality Standards N/A *
February 04, 2003 Icon Laboratories Florida District Office Over-the Counter Drug/CGMP for Finished Pharmaceuticals/Adulterated N/A *
February 04, 2003 Merits Health Products Co., Ltd. Center for Devices and Radiological Health Quality System Regulation/Adulterated N/A *
February 03, 2003 Terre Haute Regional Hospital Detroit District Office Mammography Quality Standards N/A *
February 03, 2003 Ultracell Medical Technologies New England District Office Quality System Regulation/Good Manufacturing Practice for Medical Devices/Adulterated N/A *
January 31, 2003 State Fish Company, Inc. Plant 1 Los Angeles District Office Seafood HACCP/Adulterated N/A *
January 30, 2003 Shiro and Associates San Francisco District Office FD&C Yellow No. 5/Undeclared Color Additive/Adulterated/Misbranded N/A *
January 30, 2003 Grove River Mills Inc. Atlanta District Office Animal Proteins Prohibited in Ruminant Feed/Adulterated/GMP for Medicated Feeds N/A *
January 30, 2003 Boersma #2 Dairy Los Angeles District Office Edible Tissue/Adulterated N/A *
January 30, 2003 Grove River Mills Inc. Atlanta District Office CGMP for Medicated Feeds/Adulterated N/A *
January 30, 2003 Activa Brand Products, Inc. Center for Devices and Radiological Health Quality System Regulation/Adulterated N/A *
January 29, 2003 Taproot Dairy LLC Atlanta District Office Illegal Drug Residue, Animal Tissue/Adulterated N/A *



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ICECI Warning Letters

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Food and Drug Administration

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