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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
April 28, 2004 ChiRhoClin, Inc. [ARCHIVED] Baltimore District Office Postmarketing Adverse Drug Experience Reporting Requirements N/A *
April 28, 2004 Pilgrim's Pride Corporation [ARCHIVED] Atlanta District Office Good Manufacturing Practice for Medicated Feeds/Adulterated N/A *
April 28, 2004 Tri-Med Laboratories, Inc. [ARCHIVED] New Jersey District Office CGMP in Manufacturing, Processing, Packing or Holding/CGMP for Finished Pharmaceuticals/Adulterated N/A *
April 27, 2004 Anthony's Fish Grotto, Inc. [ARCHIVED] Los Angeles District Office Seafood HACCP/Adulterated N/A *
April 27, 2004 Clinical Pharmacies, Inc. [ARCHIVED] Los Angeles District Office Quality System Regulation/Adulterated N/A *
April 26, 2004 Positron Corporation [ARCHIVED] Dallas District Office Quality System Regulation/Adulterated N/A *
April 23, 2004 Bescon Co., Ltd. [ARCHIVED] Center for Devices and Radiological Health Quality System Regulation/Adulterated N/A *
April 23, 2004 STAAR Surgical [ARCHIVED] Center for Devices and Radiological Health Sponsor Obligations N/A *
April 23, 2004 Sunder Biomedical Tech Co. [ARCHIVED] Center for Devices and Radiological Health Quality System Regulation/Adulterated N/A *
April 23, 2004 Daley Farms, LLP [ARCHIVED] Minneapolis District Office Illegal Drug Residue, Animal Tissue/Extra Label Drug Use N/A *
April 22, 2004 Lyrek Farms [ARCHIVED] Minneapolis District Office Illegal Drug Residue in Animal Tissue/Extralabel Drug Use/Adulterated N/A *
April 22, 2004 Udder Delight Dairy [ARCHIVED] Baltimore District Office Illegal Drug Residue in Animal Tissue/Extralabel Drug Use/Adulterated N/A *
April 21, 2004 Old Hickory Medicine Company, Inc. [ARCHIVED] New Orleans District Office Current Good Manufacturing Practice for Finished Pharmaceuticals/Misbranded/Adulterated N/A *
April 20, 2004 Surgilight, Inc. [ARCHIVED] Florida District Office Quality System Regulation/Adulterated N/A *
April 19, 2004 Able Laboratories Inc. [ARCHIVED] New Jersey District Office Postmarketing Adverse Drug Experience Reporting Requirements N/A *
April 19, 2004 ITV Direct, Inc. [ARCHIVED] New England District Office New Drug/Misbranded N/A *
April 19, 2004 Berkshire Valley Holsteins [ARCHIVED] New York District Office Illegal Drug Residue in Animal Tissue/Extralabel Drug Use/Adulterated N/A *
April 16, 2004 Case Western Reserve University [ARCHIVED] Center for Devices and Radiological Health Good Laboratory Practices N/A *
April 16, 2004 Canam Medsource Ltd [ARCHIVED] Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated N/A *
April 16, 2004 KBD, Inc. [ARCHIVED] Cincinnati District Office Quality System Regulation/Adulterated N/A *



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ICECI Warning Letters

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Food and Drug Administration

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Rockville, MD 20857
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