FDA Completes More Inspections than Anticipated in Fiscal 2021

The FDA issued an update yesterday on its inspection performance for fiscal 2021, indicating that it had surpassed its projections for completed inspections by more than 30 percent due to new approaches introduced during the pandemic.

The agency had estimated in May that it could complete 851 human and animal medical product surveillance inspections by Sept. 30, but actually achieved 1,139 inspections.

In the update to its Resiliency Roadmap for FDA Inspectional Oversight, the agency said that the better-than-expected performance under its “base-case” moderate projection scenario was the result of innovations, such as remote record reviews and mutual recognition agreements with other regulatory agencies.

Of all new product applications the FDA has received since March 2020, decisions on 60 are “currently delayed solely due to the inability to conduct inspections or facility assessments” as of Sept. 30, the agency said.