The U.S. Food and Drug Administration (FDA) recently announced plans to expand the use of unannounced inspections at foreign manufacturing facilities that produce food, essential medicines, and other medical products. The news comes after the agency introduced an unannounced inspection pilot program in India and China, and the agency intends to “ensure that foreign companies will receive the same level of regulatory oversight and scrutiny as domestic companies.”

“For too long, foreign companies have enjoyed a double standard, given advanced notice before facility inspections, while American manufacturers are held to rigorous standards with no such warning. That ends today. This is a key step for the FDA as part of a broader strategy to get foreign inspections back on track,” said FDA Commissioner Martin A. Makary, MD, MPH.

FDA will evaluate its own foreign inspection program and clarify certain policies, such as FDA investigators’ requirements to refuse travel accommodations from regulated industry to ensure integrity in the oversight process.

FDA conducts about 12,000 domestic and 3,000 foreign inspections per year, in more than 90 countries, the agency reports.

“While U.S. manufacturers undergo frequent, unannounced inspections, foreign firms have often had weeks to prepare, undermining the integrity of the oversight process,” FDA stated. “Despite the advanced warning that foreign firms receive, the FDA still found serious deficiencies more than twice as often than during domestic inspections.” To date, domestic inspections have only been announced in cases where companies needed to prepare records or ensure key personnel were available, and domestic companies have never been able to negotiate the day or time of an inspection, and neither should foreign companies, the agency stated.

“The FDA’s rigorous, science-based global inspections of manufacturing facilities ensure that the food and drug products that enter the U.S. marketplace, and the homes of American consumers, are safe, trusted, and accessible,” said Michael Rogers, assistant commissioner for inspections and investigations. “These inspections provide real-time evidence and insights that are essential for making fact-based regulatory decisions to protect public health.”