FDA Expands Unannounced Inspections at Foreign Manufacturing Facilities to Enhance Regulatory Oversight

On May 6, 2025, the U.S. Food and Drug Administration (FDA) announced an expansion of its unannounced inspection program to include foreign manufacturing facilities producing food, essential medicines, and medical products for the U.S. market. This initiative builds upon a pilot program conducted in India and China, aiming to align foreign inspection protocols with domestic standards. Historically, foreign manufacturers received advance notice of inspections, unlike their U.S. counterparts who undergo unannounced evaluations. Despite prior warnings, foreign inspections have revealed serious deficiencies more than twice as often as domestic ones. The FDA's enhanced approach seeks to eliminate this disparity, ensuring that all products entering the U.S. are safe and manufactured under consistent regulatory scrutiny. Additionally, the FDA plans to revise policies to prevent inspectors from accepting travel accommodations from regulated entities, thereby maintaining the integrity of the oversight process. The agency emphasizes that any attempts by firms to delay, deny, or limit inspections may result in regulatory action.