All Posts

You Don’t Pass an FDA Inspection the Week Before. You Pass It Every Day. There’s a persistent myth in life sciences that inspection readiness is something you achieve right before an audit — a flurry of binder updates, a few mock walkthrough sessions, maybe a late Friday afternoon spent closing out that deviation from Q2. I’ve spent over a decade helping companies prepare for FDA inspections, and I can tell you: that approach doesn’t work. And more importantly, it doesn’t hav

There’s a building in San Francisco’s Mission District that I think about sometimes. From the outside, it looks fine. Functional, even. But step inside and you’ll find hallways that lead nowhere, stairwells that don’t connect floors logically, rooms that were clearly added as afterthoughts — a storage closet awkwardly wedged between what used to be two offices, a bathroom accessible only by walking through someone else’s workspace. Nobody planned it that way. It just… grew. I

The quality management system documentation looks pristine. Every SOP is numbered, approved, and filed correctly. The audit reports came back clean. Your contract manufacturing organization (CMO) checked every box during the selection process. Then the first batch deviation lands in your inbox, and suddenly you’re navigating a quality incident at a facility you don’t control, with a team you didn’t hire, following processes you didn’t write. Welcome to one of biotech’s most u

When Your CMO’s Quality System Looks Great on Paper (But Reality Hits Differently) You’ve done everything right. You’ve vetted your Contract Manufacturing Organization, reviewed their quality management system documentation, confirmed their certifications, and signed the contract. Their QMS looks polished, comprehensive, and FDA-ready. Then you get the first batch deviation report. The manufacturing team missed a critical in-process check. The deviation investigation took thr