How long before an FDA inspection should the readiness assessment start?
A typical pre-inspection readiness assessment starts 2-3 months before the inspection.
FDA Inspection Support
FDA inspection support services for pharmaceutical manufacturers. The engagement covers the pre-inspection readiness, the mock inspection, the documentation preparation, the inspector response, the CAPA, and the post-inspection follow-up.
Pre-inspection readiness
The pre-inspection readiness covers the documentation review, the system walkthrough, the interview preparation, the tour preparation, the data review, the CAPA review, and the inspector scenario.
Mock inspection
The mock inspection covers the documentation request, the system walkthrough, the interview, the data review, the finding classification, and the CAPA recommendation.
Inspector response
The inspector response covers the data retrieval, the documentation provision, the interview support, the clarification, the commitment, and the follow-up.
How to use this page
Use this FDA Inspection Support page as a planning checkpoint before vendor selection, architecture review, validation scoping or implementation sequencing. The strongest next step is to compare the guidance with your current SOPs, system inventory, batch records, data flows and QA review routines so the discussion starts from evidence instead of assumptions.
Evidence to prepare
For FDA Inspection Support, prepare the records, owners, risks and decision criteria linked to pre-inspection readiness, mock inspection, inspector response. Useful evidence includes current process maps, interface lists, audit trail expectations, exception workflows, data retention rules and the business reason for changing the current operating model.
Frequently asked questions
What is the difference between FDA inspection and mock inspection?
A mock inspection is a simulated inspection conducted by the practice. An FDA inspection is the actual inspection conducted by the FDA.