FDA Inspections Standard Practice Guideline

Comprehensive training, organizational contacts, and meticulous hosting protocols for FDA inspections

What is this resource?

Overview
It is important for research teams at all participating sites to be prepared in the event of an inspection by the Food and Drug Administration (FDA). Key factors to consider include:

• How staff will be trained to interact with the FDA
• Who to contact at the university when notice is received of a pending inspection
• How to host and escort FDA inspectors
• Meeting close-out and follow-up procedures
• Policy for responding to potential FDA Inspection Observations (i.e. FDA Form 483)

When a research team member at U-M first learns that their site will be audited, this information should be immediately disseminated to other members of the research team including, where applicable, the investigator, MICHR IND/IDE Assistance Program (MIAP) staff member, study sponsor, U-M Institutional Review Board Medical School (IRBMED), Regulatory Affairs, Health System Legal Office, and Medical Records (in order to review electronic records if needed).

In addition, research team members should ensure all trial-related records are available and that a workspace for the FDA investigator(s) is provided. During the audit, it is also important that the designated liaison greets the FDA investigator(s) and verifies identification/credentials.

How this advances translational science

Implementing operations that facilitate and support the quality and impact of research