The U.S. Food and Drug Administration (FDA) announced updated plans for conducting routine inspections of domestic and foreign inspections during the COVID-19 public health emergency. In March, FDA announced that it was temporarily suspending routine inspections of domestic and foreign facilities, except “mission critical” inspections, as well as conducting remote inspections of food importers subject to the Foreign Supplier Verification Programs. FDA intends to continue suspending routine inspections for the time being and states that it will resume those inspections when local, national, and international conditions warrant.
FDA notes that it is working closely with the Center for Disease Control (CDC) to develop a process to allow the Agency to resume on-site facility inspections in a safe manner in the future. When FDA resumes inspections, the Agency expects to implement a phased approach driven by scientific data to protect the health and well-being of both FDA and state contract inspectors, as well as employees at FDA-regulated facilities.
Additionally, FDA emphasized that the Agency is confident in its ability to maintain oversight of regulated entities by leveraging available authorities, alternative tools, and scientific methods to ensure the integrity and availability of safe and quality products. However, FDA notes that the ultimate responsibility to ensure safe products lies with regulated industry.
We will continue to monitor developments related to the COVID-19 outbreak and its impact on the FDA regulated entities. Should you have any questions regarding this alert, contact Seth Mailhot, Emily Lyons, or your Husch Blackwell attorney.