Preparing For Your First Comprehensive FDA FSMA Inspection
Posted in FDA Inspection Counsel
When Congress passed the Food Safety Modernization Act(“FSMA”), it provided the framework to give FDA expansive new powers. Empowered by the new legislation, FDA is working on new rules which will grant the agency with significantly expanded authority to require written food safety, recall and food defense plans, conduct inspections, initiate investigations, mandate recalls, withdraw registration from food facilities (effectively shutting a company down), and demand access to company property and records. In addition to these new powers, FDA has also announced that it will begin relying upon criminal sanctions as a tool to compel food companies to comply with the new regulations.
Although FDA is still working on finalizing the rules under FSMA, the agency has become increasingly aggressive in its interaction with industry. FDA is now conducting FSMA-style inspections which are becoming increasingly intrusive. In addition to conducting comprehensive inspections within a facility (and identifying alleged problems and recording critical observations), the agency is now demanding access to comprehensive operational and distribution records. During its inspections, FDA has also begun conducting comprehensive environmental sampling of food facility processing and warehouse areas in an attempt to find pathogens of concern.
In the event FDA finds pathogens in the environment, such as Listeria Monocytogenes, the agency will require the company to take significant steps to remediate the issues. If the agency believes that the findings relate to a food safety concern, the agency may urge the company to issue a recall. Additionally, FDA will issue a Form 483 (documenting the agency’s critical findings), and may issue a warning letter threatening to shut the company down.
It is critical that you begin planning today for your next FDA inspection. Be sure that your facility is in an optimal condition to withstand unwanted FDA scrutiny. You should also make sure that all of your policies and procedures are consistent with the expected requirements of FSMA and what the agency will expect to see when it arrives. This includes all of your daily operational and monitoring records confirming that you are, indeed, following each of your written prerequisite and food safety programs. In the event FDA finds any discrepancies in these records, the agency may use those inconsistencies to argue (sometimes incorrectly) that you have broader underlying a food safety issue. As experienced FDA lawyers, we have helped countless food companies prepare for and also resolve probelms and concerns that develop during the course of these FDA inspections.
Finally, make sure that you are appropriately conducting environmental sampling in your facility. It is important to develop and follow an environmental sampling plan now, so that you can identify and resolve any potential problems within your facility before the FDA conducts its own sampling and finds those problems first. You should also conduct mock FDA inspections to train for the event, and also to identify any potential weaknesses in your systems.
With some proactive planning, you can position yourself now to pass your fist FSMA inspection without concern. If you wait until FDA arrives at your facility, however, you may quickly learn that it’s too late.