FDA Releases Updates on Surveillance Inspections During COVID-19
On May 11, 2020, the U.S. Food and Drug Administration (FDA) released a statement with updates on surveillance inspections during COVID-19.
According to the statement, FDA will continue to use alternative inspection tools during the COVID-19 pandemic, while domestic and foreign routine inspections are postponed.
In their March update, FDA Focuses on Safety of Regulated Products While Scaling Back Domestic Inspections, FDA stated alternative inspections may include evaluation of records, among other things.
From the FDA:
Importantly, 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. 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.
Routine inspections will be postponed as long as local, national and international conditions warrant. The FDA is currently working with the CDC to determine an appropriate timeline and processes for on-site facility inspections, as outlined in the White House Guidelines for Opening Up America Again. This process will likely be a phased approach to protect the health of workers and inspectors.
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