GUIDANCE Final
Processes and Practices Applicable to Bioresearch Monitoring Inspections
ABSTRACT — EDITORS' SUMMARY
How BIMO inspections work in practice — communication before, during, and after inspection, record access requirements, Form FDA 483 process. Mandated by FDORA §3602.
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PDF · CANONICAL LINK https://www.fda.gov/media/179027/download ↗ RELATED · SAME AUTHORITY