The FDA Inspection Cheat Sheet

FDA asks for the original record. Your team has the investigation summary. Who pulls the source data, who tracks what was handed over, and who tells the Investigator when the rest will be available?

I created The FDA Inspection Cheat Sheet for the people making those decisions while the inspection is underway. It’s a five-page field guide for U.S. finished drug manufacturing sites, written from my experience on both sides of the inspection table.

What you’ll get

• A fillable desk reference for the first 30 minutes. Name your inspection lead, backup, escort, scribe, and escalation contacts before FDA arrives.
• A request handoff table. See who captures, assigns, verifies, provides, and reconciles each request. Track what FDA received and what’s still outstanding.
• Guidance for difficult conversations and sensitive requests. Get examples of how to correct an earlier answer or explain a difference between the SOP and actual practice, plus quick references for record access, photos, affidavits, and samples.
• A worked laboratory investigation. The original assay failed. The retest passed. Quality released the lot. See what I’d ask for next and what evidence could change my assessment.
• A closeout and Form FDA 483 follow-up checklist. Capture observations, assign owners, and track response commitments and effectiveness checks.

Print the first page and keep it on the desks of the people who may take part in the inspection, from reception and the support room to Quality, Operations, and the lab.

Format · Five-page downloadable PDF with a fillable first page.