The FDA will suspend most foreign inspections through April due to the coronavirus outbreak. Inspections outside the U.S. deemed mission-critical will still be considered on a case-by-case basis.
In a statement, the FDA said, “We are aware of how this action may impact other FDA responsibilities, including product application reviews. We will be vigilant and monitor the situation very closely and will try to mitigate potential impacts from this outbreak in lockstep with the whole of the federal government. We stand ready to resume foreign inspections as soon as feasible.”
As an interim measure, the FDA is employing additional tools to ensure the safety of products imported to the U.S. These include denying entry of unsafe products into the U.S., physical examinations and/or product sampling at our borders, reviewing a firm’s previous compliance history, using information sharing from foreign governments as part of mutual recognition and confidentiality agreements, and requesting records “in advance of or in lieu of” on-site drug inspections.
Related: FDA Reopens Comment Period on Food Standards of Identity; Costco Named First VQIP Participant.
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