FDA inspections

Any FDA-regulated clinical study regardless of study sponsor can be inspected by the FDA. The FDA is allowed to inspect a site’s records under 21 CFR 312.68 and/or 21 CFR 812.145. These inspections can either be considered routine or for cause. The inspection may occur as a result of, but not limited to, an investigational product being submitted for FDA approval, a complaint or serious adverse event(s). The goal of an FDA inspection is to ensure participant safety, protocol compliance and data integrity as it relates to the study.

OVPRI’s FDA program is available to support study teams before, during and after an FDA inspection. Additional information about the types of FDA inspections and what to expect is located in the FDA program’s manual.

VCU has an institutional requirement to be notified of FDA inspections in accordance with compliance notice 17-002: Notification requirement for research studies that are subject to external audit or inspection.

Tip sheets for FDA inspections

• Prior to the inspection
• During the inspection
• After the inspection

FDA guidance

• FDA information sheet guidance: FDA inspections of clinical investigators
• Chapter 46 of FDA bioresearch monitoring manual: Clinical investigators and sponsor investigators