In December 2025, FDA issued the final guidance “Processes and Practices Applicable to Bioresearch Monitoring (BIMO) Inspections.” The document describes FDA’s processes and practices for BIMO inspections and recommends communication practices with regulated parties in advance of, during, and after an inspection. The guidance is nonbinding.
What it covers (high level):
- Background and authority for BIMO inspections, including expectations for providing FDA access to relevant records and information (including electronic systems), while noting inspections should be conducted reasonably and with applicable safeguards.
- Inspection types and context (e.g., inspections supporting a submission/application, periodic oversight of ongoing activities, and inspections linked to potential noncompliance or safety issues; comprehensive vs. directed).
- International inspections: foreign and domestic inspections are generally similar, with some practical differences (e.g., domestic inspections may include issuance of a notice of inspection, while foreign inspections generally do not).
- Communication best practices: pre-announcement purpose, discussing requested records and timelines, and closeout expectations.
- After the inspection: possible issuance of Form FDA 483 (“observations of objectionable conditions and practices”), encouraged written responses within 15 U.S. business days, inspection classifications (No Action Indicated, Voluntary Action Indicated, Official Action Indicated), and provision of the Establishment Inspection Report (EIR) once closed.
More info here.