FDA to expand use of unannounced inspections at foreign facilities

The US Food and Drug Administration (FDA) announced its intent to expand the use of unannounced inspections at foreign manufacturing facilities that produce foods, essential medicines, and other medical products intended for American consumers and patients.

This change builds on the agency’s Office of Inspection and Investigations Foreign Unannounced Inspection Pilot program in India and China and aims to ensure that foreign companies will receive the same level of regulatory oversight and scrutiny as domestic companies.

This expanded approach marks a new era in FDA enforcement - stronger, smarter, and unapologetically in support the public health and safety of Americans, the agency stressed.