FDA Inspection Readiness (Quality)

FDA inspection readiness from a quality perspective focuses on ensuring that quality systems, documentation, and operational practices can withstand regulatory inspection. FDA inspections assess not only written procedures but also how those procedures are implemented in practice.

Inspection readiness activities often involve reviewing quality systems, training records, deviation handling, and CAPA effectiveness. Preparing teams to respond clearly and consistently to investigator questions is a critical component of readiness.

Proactive inspection readiness reduces disruption, supports confident inspection performance, and minimizes the risk of regulatory observations.

Quality-focused inspection readiness typically includes:

• Quality system and documentation review

• Mock inspections and readiness assessments

• Inspection risk identification

• CAPA and deviation review

• Support during active FDA inspections