January 28, 2022
Due to the coronavirus pandemic, the US Food and Drug Administration (FDA) has further delayed inspection plans, at least until February 4, 2022. The regulator had planned a prolonged inspection pause in 2021, with the last inspection being between December 29, 2021 and January 19, 2022. However, the COVID-19 public health emergency continues to impact agency operations, pausing critical activities including inspections.
FDA domestic surveillance activities delayed
While keeping a watch on COVID-19 and its various variants like Omicron, FDA will continue to perform mission-critical inspections within the US and abroad; however, the agency will pause domestic surveillance inspections. The goal is to restart the activities “as soon as safely possible.” Although FDA inspectors have country clearance and fall within the Centers for Disease Control and Prevention’s (CDC) Level 1 or Level 2 COVID-19 travel recommendations, inspectors’ travel will have to be rescheduled if CDC requirements are not met.
We hope that by April, the regulator will indeed “return to a regular cadence for foreign surveillance inspections.”
More reliance on remote inspection and assessment processes
FDA has become innovative and very stringent in leveraging critical tools like remote assessments and import operations surveillance to help with its alternative approaches to physical inspections. The agency plans to reassess its overseas oversight mission, as well. But in announcing the temporary halt earlier in January, FDA said it was “postponing the planning of prioritized surveillance foreign inspection assignments that were scheduled to begin in February 2022.”
In May 2021, FDA published a report explaining its pandemic-era approach to remotely conducting compliance inspections, as well as how the agency prioritizes oversight and inspection activities as it continues to grapple with the COVID-19 public health emergency. (A follow-up report was issued in November 2021.) At least through early February, this approach will remain in place.
Vanita Khatter is Regulatory Services Regional Manager at UL ComplianceWire.
Additional FDA regulatory resources from UL ComplianceWire and Emergo by UL:
- UL ComplianceWire® LMS support for life sciences companies and manufacturers
- UL ComplianceWire® Emergency Use Qualification for vaccine producers and developers
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