On Tuesday, the U.S. Food and Drug Administration (FDA) announced a major expansion of unannounced inspections at foreign manufacturing sites producing
food, medicines and medical devices for the U.S. market. This marks a strategic move to align regulatory oversight of international facilities with the standards applied
to domestic manufacturers.
The initiative builds upon the FDA’s Foreign Unannounced Inspection Pilot program in India and China, addressing what Commissioner Dr. Martin A. Makary called a “double standard” that has allowed foreign firms advanced notice of inspections—an advantage not granted to their U.S. counterparts. “That ends today,” said Dr. Makary. “We are restoring parity in regulatory enforcement.”
The FDA conducts around 12,000 domestic and 3,000 foreign inspections annually across over 90 countries. Noteably, the agency has found serious deficiencies in foreign facilities more than twice as often as in domestic ones, even with prior notice. This expansion will also include strengthened policies to prevent FDA investigators from accepting travel or lodging from inspected entities, further ensuring inspection integrity.
The move is part of a broader push to reinforce U.S. supply chain safety and protect public health. FDA emphasized that it holds authority to act against companies that obstruct unannounced inspections. With this bold shift, the FDA aims to ensure all products entering the U.S. are safe, authentic and manufactured under consistent regulatory scrutiny.
To read the full article, click here