FDA’s domestic biopharma inspections return to normal as agency faces backlog of 8,000+

For the first time since March 2020, the FDA’s inspections of US-based biopharma sites have returned to normal, FDA acting commissioner Janet Woodcock said Monday at a small business regulatory event.

“I’m pleased to say that as of this month, we’ve begun transitioning back to standard operations for domestic inspections while continuing to prioritize mission-critical work for foreign inspections,” Woodcock said.