Source: U.S. Food & Drug Administration
The U.S. Food and Drug Administration (FDA) announced it will expand unannounced inspections at foreign manufacturing facilities that produce food, essential medicines, and medical products for the U.S. market. This move aims to eliminate the double standard that has allowed foreign firms to receive advance notice while U.S. manufacturers undergo surprise inspections. Building on a pilot program in India and China, the new policy ensures that foreign and domestic companies face equal regulatory scrutiny.
The FDA conducts around 12,000 domestic and 3,000 foreign inspections annually, and data shows foreign inspections reveal serious deficiencies at twice the rate of domestic ones—even with advance notice. The FDA will also review internal policies to prevent regulated companies from offering travel accommodations to inspectors, preserving the integrity of the oversight process. The initiative is part of a broader strategy to ensure product safety, expose violations, and protect public health through more robust and impartial global regulatory enforcement.