The U.S. Food and Drug Administration (FDA) announced the expansion of unannounced “for cause” surveillance inspections to now include foreign manufacturers who producing FDA regulated commodities, including food, drugs, and medical products for American consumers. The implementation of these surprise inspections, which was announced on the 6th of May, 2025, means both American and foreign manufacturing facilities are now subject to the same standards, eliminating the double standards of the past which had afforded foreign manufacturers ample time to prepare for inspections after receiving notices in advance from the regulatory body.
Despite these advance notices and weeks to prepare, the FDA reports that foreign facilities, when compared to their American counterparts, showed serious deficiencies at more than twice the rate of domestic facilities over the past five years. Notably, 32% of foreign inspections requiring Offical Action Indications – the FDA’s most severe compliance classification- were linked to correctable issues that had been temporarily concealed during pre-announced inspections.