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FDA compliance actions

This article was originally published in The Gray Sheet

Executive Summary

Device center's Division of Bioresearch Monitoring issued 48 warning letters in FY 1994, up from 18 for FY 1993, according to Office of Compliance staffers. During FY 1994, the division also suspended five institutional review boards, initiated one automatic detention, and made 15 recommendations to the Office of Device Evaluation to reject or re-evaluate data as a result of BIMO's clinical investigation audits. For the entire device center, 117 warning letters were approved in FY 1994, slightly more than the FY 1993 total of 104, and 25 seizures were approved, down from 40 in the previous year. In addition, the center approved seven injunctions and five civil penalties actions during the last fiscal year, compared to 10 injunctions and six civil penalties in FY 1993
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