When an FDA inspector comes to a facility, the risk manager should:

Regulatory inspections must be handled professionally with controlled communication and documentation practices. Verifying credentials ensures the inspection is legitimate. Accompanying the inspector supports accurate information exchange, maintains chain-of-custody for requested materials, and helps ensure staff do not speculate or provide inconsistent answers. Risk management objectives include ensuring compliance, protecting patient safety, reducing regulatory penalties, and documenting interactions for follow-up. Facilities should have an inspection readiness plan: designated escorts, document control, subject matter expert availability, and a process to log requests and responses. This approach reduces operational disruption, supports transparency, and demonstrates a mature compliance culture.