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FDA Office of Regulatory Affairs

This article was originally published in The Tan Sheet

Executive Summary

Recalls enterprise system under development will be "agency-wide, unified database that will provide accurate, real-time information, as well as archival data" accessible to industry, consumers, other regulatory bodies or FDA personnel, Associate Commissioner for Regulatory Affairs Dennis Baker announces at FDLI 44th Annual Educational Conference. Saying FDA is "reengineering the recall process," Baker explains system is based on prototype used by Center for Devices & Radiological Health for last three years. Agency is considering manufacturer incentive plan to encourage compliance by reducing inspection frequency after two consecutive positive reviews. FDAer notes 12.4% of 15,146 FY 2000 plant inspections were violative. Of those, 19.1% were human drugs, 10.2% foods and 13.9% cosmetics

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