Yesterday, the U.S. Food and Drug Administration (FDA or the agency) announced via a Press Release its intent to expand use of unannounced inspections at foreign manufacturing facilities that produce foods (human and animal), medicines, and other products intended for consumption in the U.S..

According to the Press release, FDA currently conducts approximately 12,000 domestic and 3,000 foreign inspections annually in over 90 countries. The Press Release also indicates that historically foreign firms have received advanced notice prior to inspections. This initiative, the agency explains, is designed to align the regulatory oversight of foreign companies with that applied to domestic firms.

In the Press Release, FDA Commissioner Martin A. Makary, M.D, M.P.H. stated: “For too long, foreign companies have enjoyed a double standard-given advanced notice before facility inspections, while American manufacturers are held to rigorous standards with no such warning. That ends today. This is a key step for the FDA as part of a broader strategy to get foreign inspections back on track.”

Additionally, FDA will review and improve its foreign inspection policies, including clarifying that FDA investigators should not accept travel accommodations from regulated industries.

If you have any questions regarding this information, please notify AFOA Staff and they will connect you with AFOA’s General Counsel.