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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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2001 Warning Letters

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Warning Letters for 2001

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* 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 12, 2001 Gel Spice Company Inc. [ARCHIVED] New York District Office Brazilian Black Pepper/Not Held Intact N/A *
February 12, 2001 Continental Airlines [ARCHIVED] Baltimore District Office Interstate Conveyance Sanitation Regulations N/A *
February 12, 2001 Howard County General Hospital [ARCHIVED] Baltimore District Office Mammography Standards N/A *
February 12, 2001 Bioray Inc. [ARCHIVED] Center for Devices and Radiological Health Lacks Premarket Approval/Not Substantially Equivalent/Misbranded/Adulterated N/A *
February 12, 2001 Women Care [ARCHIVED] Minneapolis District Office Mammography Standards N/A *
February 12, 2001 Nubenco Enterprises Inc. [ARCHIVED] New Jersey District Office HIV 1 + 2 Test Kits/Lacks Premarket Approval/Export Regulations/Listing Requirements/Adulterated N/A *
February 12, 2001 Frank Chaves & Sons Dairy [ARCHIVED] San Francisco District Office Food/Cattle/Adulterated N/A *
February 12, 2001 Beranbaum Khilnani Neistadt Jacobs Hertz & Sherman MDs P.C. [ARCHIVED] New York District Office Mammography Standards N/A *
February 12, 2001 Long Island Jewish Radiology Private Practice [ARCHIVED] New York District Office Mammography Standards N/A *
February 12, 2001 Basik Swift & Determined [ARCHIVED] Cincinnati District Office Veterinary Syringes/Not Held Intact for Inspection/Import N/A *
February 12, 2001 UW Health/West Clinic [ARCHIVED] Minneapolis District Office Mammography Standards N/A *
February 09, 2001 Perstrop Specialty Chemicals AB [ARCHIVED] Center for Devices and Radiological Health Quality System Regulation/Gels Pads & Powders with Iodine/Adulterated N/A *
February 09, 2001 CoPharma Inc. [ARCHIVED] Office of Enforcement GMP of Manufacturing of Bulk Products/Adulterated N/A *
February 09, 2001 Kingman Regional Medical Center [ARCHIVED] Los Angeles District Office Unlicensed Blood Band & Transfusion Service/Adulterated N/A *
February 09, 2001 Medical Diagnostic Imaging [ARCHIVED] Detroit District Office Mammography Standards N/A *
February 09, 2001 Lifesigns Inc. [ARCHIVED] New Orleans District Office Mammography Standards N/A *
February 09, 2001 Merck & Co. Inc. [ARCHIVED] Office of Enforcement GMP for Finished Pharmaceuticals/Biologics Licensing N/A *
February 09, 2001 Ferraris Medical Ltd. [ARCHIVED] Center for Devices and Radiological Health Quality System Regulation/Respirometers and Peak Flow Meters/Adulterated N/A *
February 09, 2001 Curtin Dairy LP [ARCHIVED] New York District Office Food/Cattle/Adulterated N/A *
February 08, 2001 Cangene Corporation [ARCHIVED] Center for Biologics Evaluation and Research GMP for Finished Products/Biologics/Establishment Licensing N/A *



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ICECI Warning Letters

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