As FDA inspection approaches evolve from QSIT to Compliance Program (CP) 7382.850, many organizations are encountering new and often complex questions around inspection expectations, documentation, and quality system readiness.
This article addresses some of the most common questions arising from this transition, focusing on how these changes may be applied in practice.
By providing clarification on key areas such as inspection scope, documentation, and risk‑based evaluation, these FAQs are intended to help manufacturers better understand where to focus, identify potential gaps, and approach inspection readiness with greater structure, consistency and awareness.