The US FDA has temporarily paused its inspectional activities to ensure the safety of its staff and the firms it regulates due to the spread of the omicron variant.
The Omicron variant, which was first discovered in November 2021, has already caused global disruption, despite reports from the UK suggesting the risk of hospitalization is about one-third of the Delta variant.
With case numbers surging, the US Food and Drug Administration (FDA) decided to implement specific temporary changes to its inspection activity on 29th December 2021 through to the 19th January.
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The agency is delaying the planning of prioritized surveillance foreign inspection assignments that were expected to begin in February. However, over this period of time, the FDA plans to continue domestic inspection work deemed “mission-critical†with the hope it can restart all activities “as soon as possibleâ€.
Additionally, state inspections under FDA contract have the choice to make inspection decisions based on their local information and mission-critical foreign inspections will continue as the agency reassesses plans when needed based on monitoring foreign travel conditions.
The FDA said it will use “other remote tools to maintain oversight of foods, drugs, medical products and tobacco.â€
This is not the first time the FDA has had to implement changes to its inspection schedule. The agency temporarily halted all domestic and foreign surveillance facility inspections in March 2020 until the week of July 20 where it began resuming prioritized domestic inspections.
From March 2020 through to March 2021, the agency reported it had completed a total of 821 mission-critical inspections, which included 29 foreign countries. Furthermore, the FDA conducted 777 prioritized domestic inspections since this work resumed in July 2020.
AstraZeneca exports
While manufacturing inspections have been paused, the FDA has authorized three lots of AstraZeneca’s COVID-19 vaccine drug substance produced at Emergent’s facility in Baltimore, Maryland.
AstraZeneca’s vaccine is not approved for use in the US, but it can be exported.
The FDA issued Emergent’s Baltimore plant with an FDA Form 483 and a directive to stop production in April after an ingredient mix up rendering 15 million doses of Johnson & Johnson’s (J&J) single-shot COVID-19 jab unusable.
The FDA authorized an emergency use authorization (EUA) for its ninth batch of the Janssen COVID-19 vaccine manufactured at Emergent’ Bayview facility to be released for public use in October 2021.