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# Can Surprise Foreign Drug Inspections Boost Safety?
- URL: https://www.fdaweb.com/can-surprise-foreign-drug-inspections-boost-safety/
- Published: 2025-06-10T12:00:00.000Z
- Updated: 2026-09-14T15:13:52.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159337

A 5/5 executive order issued by President **Donald J. Trump** to increase domestic drug production includes an intention to conduct more unannounced inspections of overseas manufacturers to meet the level of scrutiny given to domestic firms. A *Med Shadow* [post](ttps://medshadow.org/drug-manufacturer-unannounced-inspections-safety/) says the inspection policy could make a difference if FDA conducts enough foreign inspections.

“When drug manufacturing began shifting overseas in the 1970s, the pace of expansion accelerated in the early 2000s as more laboratories opened in foreign countries,” the post says. “This escalation caused FDA to fall behind with scheduled inspections. Making things even more difficult, the Government Accountability Office has highlighted the agency’s inability to hire and retain inspectors….”

The new executive order directs FDA commissioner **Martin Makary** to devise a plan to improve the inspections of overseas drug manufacturing facilities. It says the improvements “shall be funded by increased fees on foreign manufacturing facilities to the extent consistent with applicable law.” The order also directs Makary to publicly disclose the number of inspections conducted each year, broken down by country and manufacturer.

Former FDA investigator and now**\-**consultant **Patrick Stone** finds that the agency's new direction on foreign inspections may come too late to make a meaningful difference. “This will help, but how many of them will they conduct?” he told MedShadow. “They conduct so few international inspections, it will take years to catch up.”

“As of 2022,” the post says, “the number of foreign inspections had yet to return to pre-pandemic levels, and there is no distinct way to determine how many were unannounced. Whether this executive order leads to drug safety may not be immediately apparent, either, but if FDA’s data dashboard remains up to date, the impact could become clearer once inspection figures for 2025, both domestic and foreign, are available.”