The Food and Drug Administration has set a goal of restarting on-site inspection of FDA-regulated facilities the week of July 20.
Domestic inspections depend on situations in any given state and locality, according to a July 10 announcement from FDA Commission Stephen Hahn.
“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,” Hahn said in the notice. “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.”
The FDA will alert companies of the inspections to allow them to assure the safety of the FDA inspector, and that the appropriate staff are on site to assist in the process. FDA personnel will be equipped with personal protective equipment, and follow guidance from state, local and Centers for Disease Control and Prevention, according to the notice.
The FDA postponed the inspections starting in March, but have instituted virtual inspections in some cases and continued “mission critical” operations related to foodborne illness outbreaks and food recalls.
“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,” according to the announcement.
The FDA had developed a rating system, the COVID-19 Advisory Rating, to help prioritize domestic inspections using real-time data to assess the number of cases in an area. The “Advisory Level” is based on: Phase of the State, as defined by White House guidelines, and county-level statistics.
The regulatory activities will be classified as:
- Mission-critical only;
- All inspections with caveats to help protect staff who have self-identified as being in a vulnerable population; and
- Resumption of all regulatory activities.
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