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In Brief: Third-party inspections

This article was originally published in The Gray Sheet

Executive Summary

Third-party inspections: FDA expects to unveil its plans for a third-party device facility auditing program by Oct. 1, agency staffers say. The pilot, which will be announced in a Federal Register notice, is expected to last at least a year but could go longer if industry participation is light. FDA is still considering issues such as incentives for industry participation and identification of qualified third-party auditors...
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