On Wednesday, the Food and Drug Administration (FDA) said that it plans to expand unannounced inspections at foreign sites that produce food, essential medicines, and other medical products for American consumers.
The agency said it wants to ensure that foreign companies receive the same level of oversight as companies within the U.S.
"With this shift, the FDA is further ensuring that every product entering the U.S. is safe, legitimate, and honestly made. Unannounced inspections will also help expose bad actors—those who falsify records or conceal violations—before they can put American lives at risk," the FDA said in its announcement.
The regulating agency conducts an estimated 3,000 foreign inspections each year in more than 90 countries, but those foreign entities receive a warning in advance and often have weeks to prepare for the inspections — which the FDA said undermines the inspection process.
However, even with the advanced warnings, the FDA said that serious deficiencies are found more than twice as often in foreign manufacturing sites as domestic sites.
Domestic food and drug manufacturing sites only receive prior notice of an inspection in specific programs and cases.
“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 in a statement.
