Knock Knock. Who’s There? (or Quién es? or Qui est-ce? or Wer ist es?) Surprise, it’s FDA!

On May 6, 2025, FDA announced that it planned to conduct more surprise inspections at foreign manufacturing facilities that produce foods, essential medicines, and other medical products intended for U.S. consumers. The stated goals are to ensure that “foreign companies will receive the same level of regulatory oversight and scrutiny as domestic companies,” and “every product entering the U.S. is safe, legitimate, and honestly made.” This change builds on the pilot program conducted by FDA’s Office of Inspection and Investigations Foreign Unannounced Inspection, which focused on drug manufacturing facilities in India and China. FDA’s plan now expands the use of foreign surprise inspections to other countries as well as to other types of FDA-regulated facilities (foods and medical devices).

Most FDA inspections of domestic facilities are unannounced, with limited exceptions. Further, domestic facilities cannot dictate the day or time of the inspection. Foreign manufacturers, however, “often had weeks to prepare,” which FDA concludes, “undermin[es] the integrity of the oversight process.” Despite the advanced notice, FDA claims that it found “serious deficiencies more than twice as often” in its inspections of foreign facilities as compared to domestic facilities.

The discrepancy between the regulatory oversight over foreign firms is not a new concern, and the U.S. Government Accountability Office (GAO) reported in 2019, that “FDA’s practice of preannouncing foreign inspections up to 12 weeks in advance may give manufacturers the opportunity to fix problems.” GAO repeated this concern in its 2022 report and again in 2024. In 2024, Hyman, Phelps & McNamara, P.C. Counsel John Claud testified before the House Committee on Energy and Commerce Subcommittee on Oversight and Investigations about FDA’s foreign inspection program, in a hearing entitled Protecting American Health Security: Oversight of Shortcomings in the FDA’s Foreign Drug Inspection Program.”

Although FDA wants to increase the number and types of foreign inspections, the question remains how FDA will practically implement this expansion. In a recent Executive Order (E.O.) to promote domestic drug manufacturing, President Trump stated that the increase of “routine reviews of overseas manufacturing facilities involved in the supply of United States medicines” “shall be funded by increased fees on foreign manufacturing facilities to the extent consistent with applicable law.”  The E.O. is not entirely clear which fees the government intends to increase as there are, among other things, user fees for drug and device approvals, and program fees and facility fees that are paid annually.   Some fees already have a premium built-in for foreign manufacturing sites (for example, the annual facility fee for a domestic manufacturer for a finished dosage form generic drug is $231,952 for FY2025, but $246,952 for a similar foreign manufacturer). And even with increased fees attributable to foreign companies, the large number of RIFs that have affected the inspections office, among other key functions at FDA, will surely limit the number of inspections that physically can be conducted.  Further, the abrupt retirement of Michael Rogers, the FDA Assistant Commissioner for Inspections and Investigations, one day before FDA announced this plan to expand foreign inspections, is likely to disrupt or delay implementation.

We will continue to monitor the events as they unfold. In the meantime, be prepared! Although we advise foreign companies to always maintain inspection-readiness, in light of the new Administration’s announcement and priorities, we recommend taking some immediate-term actions:  assess your high-risk areas (such as those reviewed by FDA during previous inspections) through the internal audit program; conduct refresher training for all personnel who will be involved in an FDA inspection, particularly as the scope and tone may differ from other governmental authorities; and review your previous FDA inspections (and those from other regulatory bodies) to ensure completion of any open CAPAs or commitments.