They’re baaaack! FDA surveillance inspectors returned to the beat on Monday, at least for domestic operations. On Dec. 31, the agency announced a temporary freeze on all but “mission-critical” inspections to protect inspectors from Omicron. The freeze, the second forced on the agency since the public health emergency began, was supposed to end on Jan. 19, but had to be extended due to the lingering outbreak.
But now Omicron cases are down and the regular domestic surveillance inspections of labs, pharma, and medical products sites have resumed. The hope is to restart routine foreign surveillance inspections in early April, travel restrictions allowing.
During the first shutdown, FDA issued guidance on remote monitoring and drafted a Resiliency Roadmap for FDA Inspectional Oversight. The bad news is that the agency hadn’t resolved the inspection backlog created during the previous shutdown before finding itself having to shut down again at the start of January.