checklists

FDA Audits

As a result of the Food Safety Modernization Act (FSMA), the U.S. Food and Drug Administration (FDA) has ramped up food inspections across the board as part of a more proactive approach to food safety. Under the rules spelled out in FSMA, regulators must inspect all high-risk facilities every three years. All other facilities must be inspected every five years.

The role of audits, as detailed in FSMA, is to ensure companies follow science-based preventive practices that will ensure the production of safe food. But too many companies, with domestic and foreign facilities, aren’t fully equipped for FSMA’s heightened requirements or for the increased audits that are required. Training and audit preparation will be critical for any program to succeed. This training takes place at every level of the organization, from the corporate suite to the managers on the plant floor.

With the added pressure on the FDA to come in and perform these audits, it’s never been more critical that food manufacturers be prepared before, during, and after an FDA audit. So, what do companies need to do to be prepared for every step of the audit process?

TraceGains developed a series of checklists in collaboration with our partner, Jason Sapsin, Counsel at Faegre Baker Daniels and a member of its national FDA and Food Litigation and Regulatory practices. Sapsin is a former FDA associate chief counsel and is based in Boulder, Colorado.