RAPS recognizes that the current situation in Ukraine impacts our members and customers on many levels. If you are directly impacted by the current situation in the region and are challenged to meet your deadlines or obligations to RAPS, please reach out to raps@raps.org so that we can defer those challenges. Your health and safety are paramount to us.

Regulatory Focus™ > News Articles > 2022 > 2 > FDA to resume routine domestic surveillance inspections next week

FDA to resume routine domestic surveillance inspections next week

Posted 04 February 2022 | By Michael Mezher 

FDA to resume routine domestic surveillance inspections next week

Citing declining COVID-19 cases, a US Food and Drug Administration (FDA) spokesperson told Focus that the agency will resume its domestic surveillance inspection operations on 7 February 2022.
 
In emailed comments to Focus, Shelly Burgess, senior media advisor within FDA’s Office of Regulatory Affairs, said the agency decided on 2 February to resume the inspections following the extended halt the agency announced last month. “Beginning on Feb. 7, the agency will resume conducting domestic surveillance inspections across all commodities given the decline in COVID-19 cases across the country,” she said.
 
Burgess also said that FDA continues to conduct mission-critical domestic and foreign inspections, as well as use its alternative tools and remote assessments to “provide effective oversight of foods, drugs, medical products and tobacco.”
 
“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. Planning for additional foreign surveillance inspections is ongoing, with an anticipated goal of conducting foreign prioritized inspections starting in April,” Burgess said.
 
Just before the New Year, on 29 December, FDA temporarily halted much of its inspectional activities “to ensure the safety of its employees and those of the firms it regulates as the agency further adapts to the evolving COVID-19 pandemic and the spread of the omicron variant.” (RELATED: FDA temporarily halts inspections due to omicron, Regulatory Focus 5 January 2022)
 
At the time, the agency said it would halt all but mission-critical domestic and foreign inspections through 19 January, though it would “reassess plans as needed,” based on travel conditions abroad. On 19 January, Focus reported that FDA extended its temporary halt for inspections through 4 February. (RELATED: FDA extends temporary halt in inspections driven by omicron, Regulatory Focus 19 January 2022)

 

© 2022 Regulatory Affairs Professionals Society.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe