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Article: New testing facility guide replaces inspection checklist.(Food and Drug Administration inspection guidelines)(Brief Article)
- Article from:
- Inspection Monitor
- Article date:
- August 1, 1996
CopyrightCOPYRIGHT 1996 Washington Information Source, Inc. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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FDA has released a new guidance on the inspection of viral marker testing facilities, which could give inspectors more flexibility in writing up citations on HIV and other disease testing of blood.
The new Guide for Inspections of Viral Test Marker Facilities is part of a series of manuals that replace the Form 2609 checklist system.
Investigator Denise Dion, Office of Regulatory Affairs, Division of Emergency and Investigational Operations, Investigations Branch, said in interview, "We decided in consultation with CBER to do away with the checklist....ORA didn't think it gave enough flexibility. It didn't let them focus on the most important things done ...