Institutional Review Board for Health Sciences Research (IRB-HSR)

Special Issues

Inspections by an Outside Agency: Investigator Guidance for FDA Inspections


The Food and Drug Administration (FDA) Bioresearch Monitoring Program (BIMO) oversees FDA-regulated research by performing site visits to clinical investigators, sponsors, Institutional Review Boards (IRBs) and non-clinical animal laboratories. Site visits help to assure that human subjects and animals are protected from undue hazards and to verify that research data supporting new human and animal product approvals are reliable.
FDA conducts inspections to determine if investigators are in compliance with FDA regulations. Inspections can be announced or unannounced. Most inspections are routinely performed to verify data submitted to FDA (e.g., at sites enrolling the largest number of subjects), but can also occur as a result of a complaint made to FDA, due to sponsor concerns, as a result of a review division request within FDA, or based upon current and ongoing public health issues.

Preparing for an Inspection

Investigators should take the following actions when notified that an on-site inspection by FDA is going to occur:

For more information about FDA site inspections, consult the complete FDA Compliance Program Guidance Manual.

Additional Resources