Proposed Bill Seeks to Eliminate Preannounced Foreign Drug Inspections

Feb 01, 2022

Posted by Sidley Austin

Under a newly introduced bill, the U.S. Food and Drug Administration (FDA) would no longer provide advance notice of foreign drug inspections. Historically, FDA has notified drug manufacturers located outside of the United States weeks or months in advance of a planned surveillance inspection, whereas FDA typically provides no advance notice to domestic drug manufacturers. The Senate Committee on Finance recently suggested that the delay between notice and inspection gives some foreign drug facilities sufficient time to conceal noncompliance at their facilities.1  Continue reading

See all Member News