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The FDA has provided an overview of the impact of the COVID-19 on its inspectional regime for drugs, devices and biologics, which seriously impeded inspections of all but top priority manufacturing sites. While the agency is keen to resume on-site inspections for most facilities, it will carry forward the lessons learned over the past 15 months as future inspections will trend more toward virtual audits.
In a statement dated May 5, the FDA described the associated report as a roadmap for FDA inspectional oversight, which underscores the inspectional activities that have taken place since March 2020. At that point, the agency had postponed all routine inspections of domestic and foreign manufacturing sites, although some inspectional activities would resume in July. At that stage of the pandemic, the focus would be on mission-critical inspections. Sites located in areas with particularly severe COVID-19 outbreaks were pushed back in queue until local infection rates dropped, and all inspections undertaken during this phase were pre-announced.
Overall, the FDA conducted more than 820 mission-critical inspections between March 2020 and March 2021, which includes 29 inspections of sites located in foreign nations. There have been nearly 780 prioritized domestic inspections since the resumption of inspections in July as well. The FDA has received more than 13,500 applications for medical product approvals or authorizations since March 2020, although only approximately 600 of those required some sort of inspection or audit per the new inspectional priority regime.
Of this group of 600, the FDA inspected more than 440 facilities, and 68 applications were delayed by the agency’s inability to conduct the related inspection. However, the FDA stated that 61 of these did not fall into the category of mission-critical products. The remaining seven of these inspections that are deemed mission critical will be completed by the end of FY 2021.
Government shutdown hampered FY 2020 numbers
The surveillance inspection problem was not entirely alien to the FDA as it had completed only 16,920 of these out of a planned 18,000 in fiscal year 2019. At least some of that missing inspection load was due to a government shutdown that ran 35 days. The agency as a whole had planned 21,000 surveillance inspections in FY 2020, and managed to complete nearly 13,000 of these, most of which took place before the pandemic intervened.
The target of more than 26,000 surveillance inspections in FY 2021 includes some inspections the agency carried over from FY 2020. Of that number, more than 2,400 are for device manufacturing sites. Going forward, the agency intends to leverage its existing authorities to convert some in-person inspections to “remote oversight” inspections. These will be slotted into three areas by priority, the lowest of which is for post-approval inspections and routine surveillance inspections.
The middle tier of inspections will cover four scenarios, including high-risk assignments per a risk-based work plan, for-cause inspections that do not qualify as mission-critical, and application approval inspections that again fail to qualify as mission-critical. Mission-critical inspections of device facilities include those for application approvals for high priority products, and mission-critical follow-up inspections.
The plan for future inspections requires that the agency undertake a multi-year effort to update the FDA’s data platforms, which will assist in the effort to make use of next-generation compliance assessment technologies. The agency will also evaluate whether it is in need of further statutory authorization to enhance this type of oversight. For the time being, however, the FDA will stay focused primarily on mission-critical and prioritized inspections, while routine surveillance inspections will continue to occupy a lower priority while the agency makes use of “additional tools for continued regulatory oversight in protecting public health.”
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