Surviving an unannounced FDA inspection: 7 lessons learned

In January 2026, the FDA increased the rate of unannounced foreign inspections by 38%. If you ship to the US, this affects you.

The 7 lessons

• Have your front-desk script printed and trained — receptionists are the first line.
• A "shadow inspector" tracks every request and document handed over in real time.
• Pre-stage your audit-ready documents in a tested digital binder.
• Train every department on Right of Refusal and what NOT to volunteer.
• Have a war room with legal counsel on speed-dial.
• Issue a daily situation report to executives — surprise the board, and the board surprises you.
• Conduct a 30-minute end-of-day debrief with the entire response team.