On 6 May 2025, the US Food and Drug Administration (FDA) announced that it will expand the use of unannounced inspections at foreign manufacturing facilities that produce foods, essential medicines, and other medical products intended for US consumers and patients. The announcement came one day after the White House issued an Executive Order instructing FDA to provide regulatory relief to promote domestic production of critical medicines and improve FDA’s risk-based inspection regime to enhance routine inspections of foreign facilities.

On 6 May 2025, the US Food and Drug Administration (FDA) announced that it will expand the use of unannounced inspections at foreign manufacturing facilities that produce foods, essential medicines, and other medical products intended for US consumers and patients. The announcement came one day after the White House issued an Executive Order instructing FDA to provide regulatory relief to promote domestic production of critical medicines and improve FDA’s risk-based inspection regime to enhance routine inspections of foreign facilities. The expansion will build upon FDA’s existing Foreign Unannounced Inspection Pilot Program in India and China, with the aim of ensuring that foreign facilities will receive the same level of regulatory oversight and scrutiny as domestic facilities.