The U.S. Food and Drug Administration (FDA) has announced its intention to expand unannounced inspections at foreign manufacturing facilities producing food, essential medicines, and other medical products for American consumers. This initiative builds on the FDA’s pilot program in India and China and aims to ensure foreign companies receive the same level of regulatory scrutiny as domestic ones. FDA Commissioner Martin A. Makary stated that this move ends the double standard where foreign firms received advanced notice before inspections. The FDA conducts around 12,000 domestic inspections and 3,000 foreign inspections annually in over 90 countries. Despite prior warnings, serious deficiencies were found more than twice as often during foreign inspections compared to domestic ones. Unannounced inspections will help expose companies that falsify records or conceal violations, ensuring all products entering the U.S. are safe and legitimate. The FDA is authorized to take action against firms that delay, deny, or limit inspections.
— new from fda.gov
