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. Today’s guide is for food manufacturers who want to get their FDA compliance right from the start.
FDA compliance for food manufacturers rests on a few key pillars.
First, facility registration. Any facility that manufactures, processes, packs, or holds food for human consumption in the U.S. must be registered with the FDA. This applies to both domestic and foreign facilities. Registration must be renewed every two years.
Second, Current Good Manufacturing Practices. The cGMP regulations at 21 CFR Part 117 establish minimum sanitation and processing requirements for food facilities. These cover everything from personnel hygiene and plant cleanliness to equipment maintenance and pest control.
Third, FSMA Preventive Controls. Under the Food Safety Modernization Act, most food manufacturers must have a written Food Safety Plan that includes a hazard analysis, preventive controls, monitoring procedures, corrective actions, and verification activities. This is a significant compliance undertaking that requires documentation and ongoing record-keeping.
Fourth, labeling compliance. Your food labels must meet all FDA requirements — nutrition facts panel, ingredient declaration, allergen labeling, net quantity, and any applicable claims must all be accurate and properly formatted.
Building a strong compliance foundation protects your business from FDA enforcement and builds consumer confidence. If you’re a food manufacturer looking to strengthen your compliance program, we can help. Reach out anytime.
Have FDA compliance questions? Contact Capote Law Firm or call (786) 207-1174.