COVID Continued to Slow Inspection Activities in FY 2021, FDA Says

An annual report from the FDA’s Center for Drug Evaluation and Research (CDER) says the agency’s drug manufacturing inspection activities fell short of CDER’s self-determined goals in fiscal year 2021, primarily due to COVID-related restrictions.

The agency sets targets each year for the number of facilities it will inspect, aiming to classify the severity of each inspection’s findings within 90 days and complete regulatory action against the worst offenders within six months. The report says in 2021, the first full year of pandemic operations, CDER was able to make its 90-day classification deadline in only 70 percent of cases and complete only 48 percent of enforcement actions, such as issuing warning letters, on time.

Travel restrictions placed on FDA investigators early in the pandemic and only relieved when the agency resumed normal domestic inspection operations in February 2022 cut down the number of inspections CDER could complete, the report says, and the need to divert agency resources to pandemic-response efforts also slowed post-inspection decisionmaking.

Read the report here: www.fdanews.com/06-15-22-FY21FDAConOpsPerformancePublicReport.pdf. — Michele G. Sullivan