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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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2000 Warning Letters

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Warning Letters for 2000

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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
September 26, 2000 Pine Ridge Reservation Comprehensive Health Center [ARCHIVED] Minneapolis District Office Mammography Standards N/A *
September 26, 2000 Holy Cross Hospital IRB [ARCHIVED] Center for Devices and Radiological Health IRB (Institutional Review Board) N/A *
September 25, 2000 Nuclear Medicine of Central Florida Inc. [ARCHIVED] Florida District Office Thallium-201(inj.)/Lacks Approved New Drug Application/Misbranded/Adulterated N/A *
September 25, 2000 Baptist Memorial Hospital - Huntingdon [ARCHIVED] New Orleans District Office Mammography Standards N/A *
September 22, 2000 Leiner Health Products Inc. [ARCHIVED] Los Angeles District Office CGMP/Finished Pharmaceuticals N/A *
September 22, 2000 Cangene Corporation [ARCHIVED] Los Angeles District Office Good Manufacturing Practices for Blood and Blood Products N/A *
September 21, 2000 Hudson Medical Center-Medical Imaging [ARCHIVED] Minneapolis District Office Mammography Standards N/A *
September 21, 2000 SDL Incorporated [ARCHIVED] Center for Devices and Radiological Health Performance Standards for Laser Products N/A *
September 21, 2000 Ayundantes Inc. [ARCHIVED] Denver District Office Narcotic Treatment Program Standards N/A *
September 21, 2000 Clay-Park Laboratories Inc. [ARCHIVED] New York District Office CGMP/Finished Pharmaceuticals N/A *
September 20, 2000 Coldwater Fish Farms [ARCHIVED] Kansas City District Office Seafood Processing Regulations/HACCP N/A *
September 20, 2000 MCMI Food Company [ARCHIVED] Dallas District Office Seafood Processing Regulations/HACCP N/A *
September 20, 2000 TMJ Implants Inc. [ARCHIVED] Center for Devices and Radiological Health Sponsor Obligations N/A *
September 20, 2000 Carl Zeiss Inc. [ARCHIVED] San Francisco District Office Laser Products / Noncompliance N/A *
September 20, 2000 Martin Robert Z. [ARCHIVED] Center for Drug Evaluation and Research Clinical Investigator N/A *
September 19, 2000 Glaxo Wellcome S.p.A. [ARCHIVED] Center for Drug Evaluation and Research Current Good Manufacturing Practices for Sterile Pharmaceuticals N/A *
September 19, 2000 Altair Corporation [ARCHIVED] San Francisco District Office Current Good Manufacturing Practices for Medicated Feeds N/A *
September 19, 2000 Summer Sprout [ARCHIVED] Denver District Office Alfalfa Sprout/Insanitary Conditions/Adulterated N/A *
September 19, 2000 Organon Inc. [ARCHIVED] New Jersey District Office Current Good Manufacturing Practice Regulations/Steril & Non-Sterile Prodcuts N/A *
September 18, 2000 Department of Pathology and Laboratory Medicine [ARCHIVED] Chicago District Office Good Manufacturing Practices for Blood and Blood Products N/A *



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ICECI Warning Letters

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