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FDA inspections

This article was originally published in The Tan Sheet

Executive Summary

Pre-announced inspection program receives "high marks" from CHPA members and has "helped streamline routine inspections and...enhanced the goodwill and cooperation of FDA and industry," trade association says in Oct. 30 letter urging agency's Office of Regulatory Affairs to retain the program for drug manufacturing facilities. FDA expanded the system from devices to drugs and biologics in 1999 as a three-faceted pilot program - pre-announced inspections, annotated 483 inspection reports and formal notification of positive inspection results. ORA currently is evaluating the program's status as part of its resource utilization review, the agency says
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