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FDA uses Compliance Program Guidance Manuals (CPGM) to direct its field personnel FDA's BIMO inspections can occur at any time during a clinical trial, Dec 14, 2021 — Q: How are inspections assigned domestically in the United States Q: What's the thought/guidance for providing a BIMO reviewer's guide BIMO's authority is set forth in 21 CFR 312.68: Inspection of 9 Appendix II: FDA Site Inspection Supplemental Checklist .They will then verify the information on the 482 (notice of inspection). Determine the overall organization of the clinical research activities and monitoring Mar 18, 2019 — BIMO Inspection Readiness: A Checklist · Don't allow protocol deviation, unless it is a matter of safety. · Practice regular communication. · Have FDA's Bioresearch Monitoring (BIMO) program is a comprehensive program of on-site inspections and data audits designed to monitor all aspects of the conduct inspection, the field investigator forwards to the BIMO reviewer (by facsimile, e- mail, or placement in the appropriate shared drive folder) any Form FDA 483.