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
Hey there. I’m Lisa Capote, an FDA compliance attorney. Today’s question for food manufacturers: is your recordkeeping actually FDA-ready?
FDA recordkeeping requirements for food manufacturers exist under multiple regulations — including the Current Good Manufacturing Practice regulations at 21 CFR Part 117, the Food Safety Modernization Act preventive controls rules, and the Foreign Supplier Verification Program rules if you import ingredients.
Under FSMA, you’re required to maintain records of your hazard analysis, preventive controls, monitoring activities, corrective actions, and verification procedures. These records need to be kept for at least two years and must be available to the FDA during inspections.
For recall situations, records help you trace issues quickly — identifying which lots were affected, where they went, and who received them. Without good records, a recall becomes far more expensive and wide-reaching than it needs to be.
FDA investigators will review your records during inspections. If your records are incomplete, inconsistent, or missing, that’s a 483 observation — and it can escalate to a Warning Letter.
Good recordkeeping isn’t just a regulatory checkbox. It protects your business when something goes wrong. If you’re not sure your records are inspection-ready, we can help you audit and strengthen your documentation system. Reach out anytime.
Have FDA compliance questions? Contact Capote Law Firm or call (786) 207-1174.