The United States Food and Drug Administration (FDA) on Tuesday (06 MAY 2025) announced it will expand its effort to conduct unannounced inspections of foreign manufacturing facilities that produce medical products and foods. This action aims to create a more level playing field between domestic and foreign inspections, as domestic inspections are typically conducted without prior notice, while foreign inspections are usually preannounced.
The move comes one (1) day after President Donald Trump signed an executive order to promote the domestic production of pharmaceutical products, including calling on FDA to step up its foreign drug inspections and re-evaluate its approach to pre-approval inspections. “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,” FDA said in its announcement.
FDA reportedly paused its unannounced foreign inspections pilot after laying off thousands of its staff on 01 APR 2025 under the Trump Administration’s reduction-in-force (RIF) effort, including many workers who were responsible for arranging inspection and travel logistics. The Associated Press reported in early MAY 2025 that the Agency has sought to rehire some of the affected travel staff.
The news also comes as some of FDA’s top inspection officials are leaving the Agency, including Agency veterans Michael Rogers, Assistant Commissioner for Inspections and Investigations, who will retire on 14 MAY 2025 after 34 years at the Agency. In an email to Focus, Rogers said “it has been my greatest professional honor to have served as the last Associate Commissioner for Regulatory Affairs (ACRA), and the first Associate Commissioner for Inspections and Investigations (ACII). It has also been extremely gratifying to work with so many talented people over the years, and to have the opportunity to lead this amazing organization through the largest reorganization in FDA’s history and into its next chapter.” He added that he has “spoken a lot about the [Office of Inspections an Investigations] OII family, but we all also have our family at home. This was my decision, and what was right for me and my family at this time.”
Other recent retirements include Alonza Cruse, Director of the Office of Human and Animal Drugs Inspectorate (OHADI), and Nancy Rolli, deputy Office Director for strategic oversight at OHADI, according to according to Pink Sheet.
Lawmakers have long been critical of FDA’s foreign inspection program and have argued that giving foreign manufacturers advance notice of inspections is unfair to domestic manufacturers, who are subject to unannounced visits. In its FY 2022 spending bill, Congress directed FDA to pilot an unannounced inspection program in India and China and expanded the pilot in FY 2023. However, the Agency offered few details as to how it would expand the unannounced inspections. It did not specify whether the unannounced inspections would be conducted in additional countries beyond India and China, nor did it provide any information as to how many unannounced inspections it plans to conduct. FDA also faces logistical challenges in conducting unannounced inspections in other countries, as it must obtain visas and make travel and lodging arrangements for its staff, who are often present to carry out the inspections for multiple weeks. “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 Makary. FDA also said it will change its inspection policies, including barring its staff from accepting lodging and transportation arrangements from regulated industries.
Domestic pharmaceutical manufacturing
FDA’s move compliments Trump’s executive order, which aims to expedite construction of pharmaceutical manufacturing facilities in the United States and calls for increased inspections of foreign drug manufacturers.
The order also directs FDA to raise its fees for foreign inspections and directs the Environmental Protection Agency (EPA) to accelerate the construction of facilities designed to manufacture prescription drugs, active pharmaceutical ingredients, and other raw materials.
Industry estimates suggest that building new manufacturing capacity for pharmaceuticals may take as long as 5 to 10 years, which the White House said is “unacceptable” from a national security standpoint.
FDA is tasked with reviewing existing regulations and guidance covering the development of domestic pharmaceutical manufacturing and to take steps to eliminate any duplicative or unnecessary requirements within 180 days.
The order also calls for enhancing the inspections of foreign facilities and calls for FDA to develop and advance improvements to the risk-based inspection regime that ensures routine reviews of overseas manufacturing facilities within 90 days of the order. It directs FDA to publicly disclose the annual number of inspections that the FDA conducts on such foreign facilities, detailing the country and the manufacturer.
The order also wants FDA to provide clearer guidance regarding its requirements for site changes, including moving production from a foreign to domestic facility.
President Trump announced that “we don’t want to be buying our pharmaceuticals from other countries because if we’re in a war, we’re in a problem, we want to be able to make our own.”
During the signing of the executive order, FDA Commissioner Mary Makary said FDA plans to soon start conducting unannounced inspections of foreign sites, a move that would level the playing field between domestic and foreign manufacturers. “We have had this crazy system in the United States where American pharma manufacturers in the United States 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. 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 Investigators hanging out for three (3) to four (4) 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.”
It remains to be seen whether FDA will be able to increase its foreign inspection activities, as the Agency has struggled with staff turnover and a backlog of inspections that was worsened by the COVID-19 pandemic. Despite its effort to ramp up inspections after the pandemic, the Associated Press reported in SEP 2024 that the Agency is still struggling to catch up with inspections of about 2,000 drug manufacturing facilities in the United States and more than 340 in India and China.
REFERENCE: Regulatory Focus (news and Peer Reviewed Content); 06 MAY 2025; Michael Mezher and Joanne S. Eglovitch