The US Food and Drug Administration (FDA) is moving to tighten oversight of foreign manufacturers supplying the US market by subjecting overseas facilities to unannounced inspections, which has long been the standard for domestic producers.
The change is aimed at closing what the agency describes as a regulatory gap, where foreign plants have received advance notice of inspections, unlike their US-based competitors.
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This expansion builds on the FDA’s Foreign Unannounced Inspection Pilot programme in India and China, and will apply to facilities producing food, essential medicines and medical products for US consumers and patients. According to FDA Commissioner Marty Makary, the new approach will allow the agency to carry out a greater number of inspections without increasing costs by shortening the duration of each site visit. Makary stated that the goal is to level the playing field and remove what he called a “double standard” in regulatory enforcement.
“This is a key step for the FDA as part of a broader strategy to get foreign inspections back on track,” said Makary in the announcement on 6 May.
The move follows an executive order signed by President Donald Trump on 5 May, directing the FDA to streamline approval processes for domestic pharmaceutical manufacturing plants. The order instructs the agency to eliminate duplicate requirements, accelerate review timelines and provide early-stage guidance to US manufacturers before new facilities become operational.
At the same time, the order directs the FDA to increase scrutiny and fees for foreign manufacturers and improve enforcement of supply chain transparency, particularly around active pharmaceutical ingredient sourcing.
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By GlobalDataThe White House has indicated that the executive order is part of a broader push to reduce reliance on foreign pharmaceutical production, building on initiatives from Trump’s first term aimed at reshoring critical drug manufacturing. The administration is also considering the public release of a list of foreign facilities that fail to meet FDA compliance standards.
“We have had this crazy system in the US where American pharma manufacturers in the US are put through the wringer with inspections, and the foreign sites get off easy with scheduled visits, while we have surprise visits in the United States,” said Makary during the signing of the executive order.
“A scheduled visit is no exception, so we at the FDA are delivering on this promise through this order and switching from preannounced to surprise inspections overseas. We are not going to have our inspectors hanging out for three to four weeks; they are going to get in and out, and we are going to do more inspections with the same amount of resources as a result,” Makary added.
This regulatory shift coincides with a broader restructuring within the Department of Health and Human Services (HHS), under which the FDA operates. In March 2025, the Trump administration announced a workforce reduction of 10,000 positions across key HHS agencies, shrinking the department’s total headcount from 82,000 to 62,000 as part of a government-wide downsizing effort.
Pharmaceutical manufacturers have already begun responding to the changing regulatory and trade environment. Several large companies have announced plans to reshore production to the US in anticipation of new trade barriers. While finished drug products were initially exempt from the 10% blanket tariff introduced in April, Trump has signalled that a separate tariff targeting pharmaceutical imports is coming soon.
