On-site inspections by the U.S. Food and Drug Administration will resume next week, according to Commissioner Stephen Hahn. The announcement that the FDA will resume domestic inspection comes with an acknowledgment that the COVID-19 crisis remains FDA’s top concern.
“However,” said Hahn, “resuming prioritized domestic inspections will depend on the data about the virus’ trajectory 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. 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 to resume domestic inspections.
Hahn said for the “foreseeable future,” domestic inspections will be pre-announced to FDA-regulated businesses as they are prioritized.
“This will help assure the safety of the investigator and the firm’s employees, providing the safest possible environment to accomplish our regulatory activities, while also ensuring the appropriate staff is on-site to assist FDA staff with inspection activities,” Hahn said.
One exception will be retail tobacco inspections, which are treated as undercover operations when they do occur.
“The health, safety, and well-being of our investigators, as well as the public, are of the utmost importance to us, ” Hahn added. “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.”
The FDA’s domestic food facilities registrations totaled 94,423 going into 2020. The data reveals that as of Dec. 31, 2019, there were 221,843 FDA-registered food facilities, with 127,420 of them, or 57 percent, located outside of the United States. FDA is responsible for periodically inspecting facilities that are registered to produce food for U.S. consumption.
The only exceptions are that fresh meat, poultry, egg, and catfish facilities, which receive continuous inspections from USDA’s Food Safety and Inspection Service. Those inspections continued during the pandemic.
The “White House Guidelines for Opening Up America Again,” call for the FDA to send out investigators for on-site inspections by the week of July 20, under a COVID-19 Advisory Rating system that uses state and national data about infection rates to determine in which regions enforcement can resume.
The rating system is also available to FDA’s state partners to help determine “mission-critical” inspections and if/when there can be a return to normal operations. State and local trends in COVID-19 infections and hospitalizations as well as the availability of other services like transportation are part of the system FDA will follow.
FDA suspended domestic and foreign inspections on March 10, including food safety inspections, because of the COVID-19 pandemic. It has continued to issue advisories and warning letters during the pause. FDA did warn consumers later in March about hand sanitizers made in Mexico with methanol or wood alcohol that could be toxic if absorbed through the skin or ingested.
FDA is part of the U.S. Department of Health and Human Services. It regulates about 80 percent of the food produced for U.S. consumption.
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