In this short video, FDA compliance attorney Lisa Capote of Capote Law Firm covers preventive controls under FSMA for food manufacturers. Watch below, then read the full transcript.
Full Transcript
Under the FDA’s Food Safety Modernization Act — FSMA — food manufacturers are required to implement preventive controls. These aren’t reactive measures you put in place after a problem occurs; they are proactive systems designed to prevent food safety hazards before they reach consumers. Preventive controls are one of the core requirements of FSMA’s Preventive Controls for Human Food rule, which applies to the vast majority of food facilities registered with FDA.
Preventive controls include a broad range of measures tailored to your specific operations. Common examples include sanitation procedures to control environmental pathogens, allergen management controls to prevent cross-contact with major food allergens, and supply chain controls to verify that raw materials and ingredients from your suppliers don’t introduce hazards into your products. Each control needs to be monitored, and records of that monitoring must be maintained to demonstrate compliance during an FDA inspection.
Getting preventive controls right requires a clear understanding of the regulatory requirements and how they apply to your specific manufacturing environment. A food law attorney can help you understand what’s required under FSMA, review your existing food safety plan, identify gaps, and ensure your controls are properly documented. The goal is to build a system that protects your customers and your business — before FDA has to get involved.
👉 Contact Capote Law Firm today for expert FSMA and preventive controls compliance guidance for your food business.