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2005 Warning Letters

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Warning Letters issued in 2005

 

* 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 01, 2005 Mayne Pharma (USA) Inc. [ARCHIVED] New Jersey District Office Postmarketing Adverse Drug Experience Reporting Requirements N/A *
February 01, 2005 Advanced Bionics Corporation [ARCHIVED] Los Angeles District Office Current Good Manufacturing Practice Regulation/Adulterated N/A *
January 31, 2005 Wax Orchard's Inc. [ARCHIVED] Seattle District Office Juice HACCP/Adulterated N/A *
January 28, 2005 Gene Logic, Inc. [ARCHIVED] Center for Drug Evaluation and Research GLP for non-clincal laboratory studies N/A *
January 27, 2005 Marcum, John W., M.D. [ARCHIVED] Center for Devices and Radiological Health Clinical Investigator N/A *
January 27, 2005 Newhouse Dairy Processing LLC [ARCHIVED] Kansas City District Office Juice HACCP N/A *
January 25, 2005 Nutraceutical Labs, Inc. [ARCHIVED] Los Angeles District Office Labeling/Dietary Supplements/CGMP for Finished Pharmaceuticals/Adulterated N/A *
January 21, 2005 E-Lyte Incorporated [ARCHIVED] New Jersey District Office New Drug/Labeling/False & Misleading Claims N/A *
January 20, 2005 Basic Research, LLC [ARCHIVED] Denver District Office Labeling/Promotional Claims False & Misleading/New Drug N/A *
January 19, 2005 GE Healthcare Technologies [ARCHIVED] Minneapolis District Office Performance Standards for Diagnostic X-ray Equipment N/A *
January 19, 2005 Crittenton Hospital Medical Center [ARCHIVED] Center for Devices and Radiological Health Institutional Review Board (IRB) N/A *
January 14, 2005 Archer Daniels Midland Company [ARCHIVED] Kansas City District Office CGMP/Medicated Feeds/Adulterated N/A *
January 14, 2005 Basic Research, LLC [ARCHIVED] Denver District Office Labeling/Promotional Claims False & Misleading/New Drug N/A *
January 13, 2005 Warehouse Food Group, LLC [ARCHIVED] New Orleans District Office Seafood HACCP/Adulterated N/A *
January 12, 2005 Brown Cattle Company [ARCHIVED] Dallas District Office Animal Proteins Prohibited in Ruminant Feed/Adulterated N/A *
January 12, 2005 Greenland, Inc. [ARCHIVED] Seattle District Office Labeling/False & Misleading Claims/Misbranded N/A *
January 10, 2005 Faaborg Rehab Technic ApS [ARCHIVED] Center for Devices and Radiological Health Current Good Manufacturing Practice/Adulterated N/A *
January 10, 2005 Cincinnati Sub-Zero Products [ARCHIVED] Cincinnati District Office Quality System Regulation/Adulterated/Misbranded N/A *
January 10, 2005 Arjo Med. AB Ltd. [ARCHIVED] Center for Devices and Radiological Health Current Good Manufacturing Practice/Adulterated N/A *
January 07, 2005 Peter Schiff Enterprises [ARCHIVED] New Orleans District Office Current Good Manufacturing Practice/Adulterated N/A *



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ICECI Warning Letters

Division of Freedom of Information (HFI-35)

Food and Drug Administration

5600 Fishers Lane

Rockville, MD 20857
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