Omicron Delays FDA Inspections, as Well as Planning of Foreign Inspections
Due to the Omicron variant of COVID-19, the FDA will postpone foreign inspection assignments that were scheduled to begin in February 2022, as well as postponing work not deemed mission-critical.
That nonessential work includes domestic and foreign surveillance inspections, investigations and sample collections that can’t be performed remotely or safely due to travel or social distancing concerns, said FDA spokesperson Devin Koontz.
While the FDA did not specifically note whether inspections under its Bioresearch Monitoring program are impacted by these new delays, it’s safe to assume they affect all of the agency’s purviews.
Some, like Kalah Auchincloss, executive vice president of regulatory compliance for compliance consulting firm Greenleaf Health, believe the FDA’s actions may be overkill.
“On the one hand, we are obviously in the midst of a huge surge of COVID-19 and the transmission rates of the Omicron variant are far greater than Delta or other variants, but at the same time, we have fairly high rates of vaccination among FDA inspectorates, and it seems like the data coming out show that omicron is not severe,” said Auchincloss. “So, I’m surprised that we’re back to this state we were in in March of 2020.”
Still, it may be the safer way to go for employees, she said, adding that she doesn’t think the delay will last long. “They’re trying to recalibrate and will probably resume delayed work in February if Omicron starts to fade, which it’s already doing in some places,” Auchincloss said.
The agency, Koontz said, will continue conducting mission-critical foreign inspections and will reassess plans as needed based on its monitoring of foreign travel conditions.
“Throughout the pandemic, we continued conducting mission-critical inspections across all FDA-regulated commodities regardless of physical site location, foreign and domestic,” Koontz said. “While the majority of mission-critical inspections have been domestic, we have successfully conducted mission-critical inspections in nearly 30 countries.”