FDA extends temporary halt in inspections driven by the Omicron COVID-19 variant

FDA previously announced it would halt certain inspectional activities out of concern for its employees and those of the companies it regulates amid the wave of COVID-19 infections driven by the Omicron COVID-19 variant.  At the time, the Agency said it would continue to conduct “mission-critical” work through 19 January 2022.  In emailed comments to Focus, Shelly Burgess, senior media advisor within FDA’s Office of Regulatory Affairs (ORA), said the Agency extended the postponement on 18 January 2022.  “The FDA is extending the pause on domestic surveillance inspections through Feb. 4 (2022) with the goal of restarting these activities as soon as safely possible,” Burgess said.

She added that 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 and import operations surveillance.”

The Agency had previously said it would postpone its planning of prioritized foreign surveillance inspections, which were scheduled to begin next month (in February 2022).  Burgess said that some of those inspections will indeed be carried out.  “The Agency will proceed with previously planned foreign surveillance inspections that have received country clearance and are within the [Center for Disease Control and Prevention] CDC’s Level 1 or Level 2 COVID-19 travel recommendation; otherwise, the inspection will be rescheduled,” she said.  She added that the Agency’s goal “is to return to a regular cadence for foreign surveillance inspections in April (2022).”

Since the pandemic hampered FDA’s ability to conduct inspections — both domestically and abroad – there have been concerns that the Agency would face a backlog of inspections.  Those concerns led to the Agency developing a “resiliency roadmap” for inspections, which FDA said it had exceeded its own projections in implementing.

REFERENCE:  RAPS (Regulatory Focus; News Articles; 2022; 1); 19 JAN 2022; Michael Mezher