U.S. FDA Announces Expanded Use of Unannounced Inspections at Foreign Manufacturing Facilities

The U.S. Food and Drug Administration 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 upon 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.

The FDA conducts about 12,000 domestic inspections and 3,000 foreign inspections each year across more than 90 countries. While U.S. manufacturers undergo frequent, unannounced inspections, foreign firms often have weeks to prepare, undermining the integrity of the oversight process. Despite this advance notice, the FDA still found serious deficiencies more than twice as often as during domestic inspections.

The FDA’s domestic inspections are pre-announced only in specific programs and cases to ensure that the necessary records and personnel are available during the inspection. Regulated companies—whether domestic or foreign—do not have the authority to negotiate the day or time of the inspection.

With this shift, the FDA aims to further ensure that every product entering the U.S. is safe, legitimate, and honestly produced. Unannounced inspections also help uncover bad actors who falsify records or hide violations before they can endanger lives. The FDA is authorized to take regulatory action against any firm that delays, denies, or limits an inspection, or refuses entry for an unannounced drug or device inspection.

Learn more about top automation trends in CPG, Food, and Beverage as well as Life Sciences and Biotech.