I recently had a warehouse manager mention that it had been twelve years since an FDA inspection. Then, one happened, and many food safety gaps were noted. The lesson here is don’t wait for a local, state or federal inspector or contract customer’s auditor to show up and tell you the basics of what you should be doing. It is expected that the basics are known and should be in place prior to conducting business. The Food Safety Modernization Act (FSMA) I trust, will not catch you unexpectedly as it received great notoriety. While FDA field inspectors may not be concentrating on food warehouses to enforce this relatively new law, don’t wait for one to show up and point out gaps in compliance, issue warning letters and put your warehouse on a more frequent inspection schedule. Don’t forget, any regulatory inspector could show up unannounced based on a consumer or competitor’s complaint. Let’s begin the FSMA journey.
The Food Safety Modernization Act (FSMA) was enacted on January 4, 2011. While it took several years for the Food and Drug Administration (FDA) to train its personnel, roll out and implement FSMA, for the most part it is now in place. Are facilities (e.g. warehouses) that receive, store and distribute human and animal food products required to be part of FSMA? In most cases, the short answer is “yes.” How would you know? The longer answer is, in general, the facility is covered if it is required to register with the FDA under section 415 of the Federal Food, Drug and Cosmetic (FD&C) Act. FSMA amended section 415 as parts of this section you may remember as the Bioterrorism Act (Public Health Security and Bioterrorism Preparedness and Response Act of 2002). This act requires domestic and foreign facilities that manufacture, process, pack or hold food for human or animal consumption in the U.S. must register with the FDA. Warehouses that handle foods requiring refrigeration or things like fresh fruits and vegetables that are exposed to the warehouse environment definitely fall into the requirement for FDA registration. Almost all warehouses handling food have to meet at least some of the requirements under the FSMA law and are subject to FDA inspections.