We run mock FDA inspections the way an investigator would, structured on the inspection method in FDA Compliance Program 7382.850 and current with the Quality Management System Regulation (QMSR).
You get the same document requests, the same interview questions, and the same pressure. The difference is that the findings go to you, with time left to fix them.
The report is written to be defended in front of a board and acted on by your team. Findings are ranked so the serious ones are not buried, and each one is specific enough to start work on the same week.
If a mock inspection turns up gaps, the same team can close them. Audits are where we start, not where we end.
When to call us
- “We have an FDA inspection in 60 days.”
- “My sites have not been audited since before COVID.”