In March, FDA temporarily halted domestic facility inspections that weren’t deemed “mission-critical” over health concerns related to the COVID-19 pandemic. However, in accordance with the White House Guidelines for Opening Up America Again, the agency has announced that on-site inspections would resume in July.
Stephen M. Hahn, MD, FDA commissioner, notes that resuming prioritized domestic inspections will depend on the data about the trajectory of the virus in a given state and locality and the rules and guidelines that are put in place by state and local governments. “In order to move to the next phase, we must see downward trends in new cases of COVID-19 and hospitalizations in a given area,” he says. “Our ability to resume is also affected by other services that have been curtailed by the pandemic, such as public transportation. The availability of these services will be an important factor in how we determine resuming domestic inspections.”
Since March 10, all domestic routine surveillance facility inspections—those traditionally conducted by FDA every few years based on a risk analysis—were put on hold. The exception to this rule were any inspections deemed as “mission critical.” Additionally, inspections for fresh meat, poultry, egg, and catfish facilities continued during the pandemic.
“We have had great success by using a number of tools as part of the agency’s risk-based approach to ensuring quality, including remote assessments and import alerts as well as other compliance requirements,” Hahn says. “As the COVID-19 pandemic continued, we adjusted our processes and guidance as necessary to maintain the appropriate level of review to ensure the safety of consumer products.”
FDA will also now pre-announce domestic inspections to FDA-regulated businesses except for retail tobacco inspections. Hahn says this should help assure the safety of the investigator and the firm’s employees, providing the safest possible environment to accomplish all regulatory activities, while also ensuring appropriate staff is on-site to assist FDA staff with inspection activities.
“The health, safety, and well-being of our investigators, as well as the public, are of the utmost importance to us,” Hahn said. “We will ensure our investigators are outfitted with personal protective equipment and are equipped with other necessary equipment to carry out their work while adhering to state and local guidance as well as applicable CDC guidance. We will continue to work to ensure our prioritized domestic inspections resume appropriately and as safely as possible.”