FDA restarts domestic drug manufacturing inspections
After a pause of 41 days, the FDA restarted its domestic pharma-related surveillance inspections on Monday.
That decision to restart, which came as a result of the steep decline in Covid-19 cases across the country, followed the agency’s previous decision to pause these domestic inspections in December.
“In addition to the resumption of planning and conducting domestic surveillance inspections on Feb. 7, the FDA continues to conduct both foreign and domestic mission-critical inspections, as well as provide effective oversight of foods, drugs, medical products and tobacco leveraging a variety of tools, including remote assessments. The agency also continues to proceed with previously planned foreign surveillance inspections that have received country clearance and are within the Center for Disease Control and Prevention’s Level 1 or Level 2 COVID-19 travel recommendation,” FDA said Friday.
The inspections have been stopping and starting since the pandemic began.
More recently, at the start of January, the FDA announced that it paused inspections not considered mission-critical for “at least two weeks” to ensure the safety of FDA employees. Somewhat normal inspections had only just resumed in July.
The pauses have had a significant impact on the biopharma industry. A November 2021 report noted that 52 new drug applications were delayed, in part due to the backlog of inspections.
Planning for additional foreign surveillance inspections is ongoing, FDA said, noting an “anticipated goal of conducting foreign prioritized inspections starting in April.”