5 Documents the FDA Will Demand on Site — Are You Ready?

In this episode of DarshanTalks, you dive into what U.S. Food and Drug Administration (FDA) inspectors will demand when they show up on-site. You walk through the five critical documents every life-sciences or pharma company should have ready, because without them, an inspection can become a deal-breaker fast.

You stress that compliance isn’t just paperwork; it’s the backbone of long-term viability. A weak document trail, sloppy record-keeping, or missing records can lead to penalties, regulatory exposure, or even shutdowns. Tight compliance and strong documentation aren’t optional. They’re deal insurance.

The episode gives concrete guidance on what to have in place before regulators knock. It’s essential listening for executives, compliance officers, and M&A advisors in biotech, pharma, and medical device businesses.

Transcript

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What are the five things that the FTA will ask for when they walk in? This is a good general direction. Delegation of authority logs, training records, informed consent forms, adverse event documentation, and drug device accountability records. These five categories, they account for most 483s. So to be inspection ready, keep these binders or e-files updated weekly and not monthly. Have a clear naming convention, have clear version control. Train staff to know where these documents are stored so that you're not scrambling. Try to have a mock inspection at least once a year. This helps identify gaps. Remember, regulators assume that if your paperwork is sloppy, the whole trial may be sloppy. Being able to hand over clean, organized records within minutes sets a tone for the entire inspection. Call, click, or email.