FDA Halts Facility Inspections as COVID-19 Spreads in USFDA Halts Facility Inspections as COVID-19 Spreads in US
March 20, 2020
The US Food and Drug Administration (FDA) said Wednesday that it will temporarily halt routine surveillance inspections at domestic facilities to protect the health of its staff as the novel coronavirus COVID-19 spreads across America.
“Today, we’re announcing that for the health and well-being of our staff and those who conduct inspections for the agency under contract at the state level, and because of industry concerns about visitors, we have temporarily postponed all domestic routine surveillance facility inspections,” FDA Commissioner of Food and Drugs Stephen M. Hahn M.D. said in a statement. “These facility inspections the FDA traditionally conducts every few years based on a risk analysis.”
The agency said it will still conduct for-cause inspections in the US if it is “mission-critical,” and continue to provide assistance in natural disasters, outbreaks, and other public health emergencies that relate to FDA-regulated products.
“During this interim period we’re evaluating additional ways to conduct our inspectional work that would not jeopardize public safety and protecting both the firms and the FDA staff,” Hahn said. “This can include, among other things, evaluating records in lieu of conducting an onsite inspection on an interim basis when travel is not permissible, when appropriate.”
A few weeks ago, the FDA announced that it was halting inspections of foreign facilities through April.
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