Preparing for an FDA inspection at your site

How often does FDA inspect investigators?

In fiscal 2023, FDA's Bioresearch Monitoring (BIMO) program conducted 681 clinical investigator inspections, well over half of all BIMO inspections that year (Goodwin).

What does FDA find most often?

From issued Form 483s, FDA lists these common clinical investigator observations (FDA; Goodwin):

1. Failure to comply with Form FDA 1572 requirements and to follow the investigational plan.
2. Inadequate or inaccurate case history records and study records.
3. Inadequate subject protection and informed consent issues.
4. Inadequate accountability or control of the investigational product.
5. Safety reporting failures, including adverse events not reported or recorded.

What do those look like in practice?

• Consent missing signatures or dates, an outdated consent version, or procedures done before consent.
• Source documentation that does not support what was entered in the case report.
• Delegation logs with tasks done by someone not delegated, vague task descriptions, or logs not updated after staff changes (CASRAI).

How do you stay inspection ready?

1. Audit consent forms for every participant against the current approved version.
2. Keep delegation logs current, with training records for each task.
3. Reconcile product accountability monthly.
4. Track and report deviations as they happen.
5. Run a mock inspection once a year.

What happens when FDA calls?

Notify the sponsor, prepare a room, designate one host, gather the regulatory binder and source records, and have the PI available. Answer what is asked, accurately. After the inspection, respond in writing to any 483 observations with corrective actions.

Why does this matter beyond compliance?

Unresolved FDA findings can materially reduce a site's value to buyers (Objective IBV) and its appeal to sponsors. Clean inspections and steady enrollment together make a site the one sponsors keep coming back to.