In this short video, FDA compliance attorney Lisa Capote of Capote Law Firm covers key FDA compliance guidance. Watch below, then read the full transcript.
Video Transcript
Hi there. I’m Lisa Capote, an FDA compliance attorney. Today, let’s talk about FDA inspections — specifically, what to expect if an investigator shows up at your dietary supplement facility.
FDA inspections of dietary supplement manufacturers focus primarily on your compliance with Current Good Manufacturing Practices, or cGMPs, which are found at 21 CFR Part 111. Inspectors will want to see your written procedures, batch records, testing results, complaint files, and training documentation.
Here’s what most manufacturers get tripped up on: the documentation. It’s not enough to have good practices — you have to be able to prove them. If it’s not written down and dated, in the FDA’s eyes, it didn’t happen.
At the end of the inspection, if the investigator found issues, they’ll issue a Form 483 — a list of inspectional observations. This is not a final action, but your response matters. A well-prepared, substantive 483 response can significantly influence what happens next.
The best way to handle an FDA inspection is to be prepared before it happens — not after. Regular internal audits, mock inspections, and proper documentation practices make a real difference.
If you receive a Form 483 or need help preparing for an inspection, reach out. We’re here to help. See you in the next video.
Have FDA compliance questions? Contact Capote Law Firm or call (786) 871-5680.