FDA Extends Postponement of Inspections Until 2/4

FDA has extended until 2/4 a temporary postponement of certain inspection activities due to the spread of the omicron variant. Late last year, the agency said it had temporarily postponed until 1/19 all face-to-face domestic and foreign inspectional work except for “mission-critical” inspections (see earlier story).

An FDA spokesperson told FDA Webview 1/20 that the agency “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 will proceed with previously planned foreign surveillance inspections that have received country clearance and are within the CDC’s Level 1 or Level 2 Covid-19 travel recommendation; otherwise, the inspection will be rescheduled. The FDA’s goal is to return to a regular cadence for foreign surveillance inspections in April.”