FDA: No plans yet to resume onsite GMP foreign inspections

Regulatory NewsRegulatory News | 25 August 2021 |  By 

An official with the US Food and Drug Administration (FDA) said the agency has no plans to resume onsite foreign inspections for operations that are not deemed “mission critical” during the COVID-19 public health emergency. Instead, the agency is relying on the expanded use of mutual recognition agreements as an alternative tool for boots-on-the-ground inspections.
So asserted Alonza Cruse, the director of pharmaceutical quality operations in FDA’s Office of Regulatory Affairs, at a 25 August webinar sponsored by the Center for Drug Evaluation and Research’s (CDER) Small Business and Industry Assistance (SBIA) webinar on manufacturing, supply chain and inspections during the COVID-129 public health emergency.
During the webinar, FDA officials discussed the impact of COVID-19 on inspections and provided a status update of the agency’s domestic and foreign inspection program.
The number of inspections has dropped significantly due to COVID. FDA’s Laurie Graham, director of the division of internal policies and programs at CDER’s Office of Pharmaceutical Quality told webinar attendees that as of March 2021, the agency conducted a total of 777 prioritized domestic inspections since resuming inspections in July 2020, and from March 2020 through March 2021, FDA conducted a total of 821 mission critical inspections, including 29 in foreign countries.
According to the Government Accountability Office (GAO), prior to COVID-19, FDA typically conducted more than 1,600 inspections of foreign and domestic manufacturing sites each year. (RELATED:  Inspections: GAO calls on FDA to plan for backlog, review alternatives, Regulatory Focus, 1 February 2021).
Using MRAs in place of onsite inspections
The lingering pandemic is continuing to limit the agency’s ability to conduct onsite inspections, said Cruse. When asked whether FDA had any plans to soon visit COVID-19 “safe” areas in Europe instead of “hot spots” in other parts of the world, he replied that FDA still does not have a fixed date for resuming foreign inspections.
Instead, FDA is expanding its use of mutual recognition agreements (MRAs) to cover third countries that are inspected by EU regulators and will accept these reports instead of conducting onsite inspections. He added that these inspections are posted in the FDA’s inspections database.
When pressed to answer when FDA will be resuming onsite inspections for active pharmaceutical ingredient (API) firms in India that have received an official action indicated (OAI) or a 483 report, Cruse said these firms have been “prioritized” as mission critical and plans are to inspect them soon.
“The staff in the India office has those assignments now. We have two detailees in India right now and we are working to post additional staff there temporarily. We have quite a few follow-up OAI inspections there to get to.”
He said that sites in China and India have been particularly problematic to staff as the result of last year’s State Department “administrative departures” order. Under this order, embassy staff, including FDA staff, had to evacuate these countries. This year, the order has been lifted and FDA staff has started to return.
Alternatives will not replace inspections
FDA officials also told the webinar that there are no plans to replace onsite inspections with remote audits and records requests. “Records requests and remote inspections do not meet the statutory requirements for a boots-on-the-ground inspection. Without a statutory change, there will be no plans to change that,” said Graham.
Under section 704(a)(4) of the FD&C Act, FDA has the authority to request records in advance of or in lieu of an inspection.
Government officials have been concerned about the pandemic’s toll on FDA’s foreign inspection program. In a March report, the GAO warned a House Appropriations Subcommittee that the agency needs to come up with a plan to address the looming inspections backlog and tackle some of its longstanding issues. (RELATED:  FDA’s inspection backlog: GAO raises concerns as delays mount, Regulatory Focus, 9 March 2021)
SBIA webinar


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