In this short video, FDA compliance attorney Lisa Capote covers key FDA compliance guidance. Watch below, then read the full transcript.
Video Transcript
Hey there. I’m Lisa Capote, an FDA compliance attorney. If you operate a dietary supplement manufacturing facility, an FDA inspection isn’t a matter of if — it’s a matter of when. Let’s make sure you’re ready.
FDA inspectors arrive at supplement facilities to verify cGMP compliance under 21 CFR Part 111. They’ll review your facility, your documentation, your quality control systems, and your records.
Here’s what they typically focus on. Batch production records — inspectors will pull records and verify that your manufacturing steps were followed, that testing was conducted, and that any deviations were documented and addressed. Master manufacturing records — your SOPs and formulation records need to be current and consistently followed. Laboratory records — results from identity testing, potency testing, and finished product testing need to be accurate and complete. Complaint files — records of consumer complaints and your responses to them are reviewed.
A critical point: inspectors are looking for evidence of a functioning quality system, not just the existence of written procedures. If your SOPs exist but aren’t being followed, that’s an observation.
At the end of the inspection, if issues were found, you’ll receive a Form 483. You have the right to respond — and a strong, substantive 483 response can significantly influence the outcome. Don’t ignore a 483 and don’t respond defensively. Address each observation with specific corrective actions and timelines.
Preparation is everything. Conduct regular mock inspections, keep your documentation current, and train your team on what to expect. We can help you get inspection-ready. Reach out anytime.
Have FDA compliance questions? Contact Capote Law Firm or call (786) 207-1174.