Unannounced Inspections of Drug Manufacturers Could Improve Drug Safety — If It Actually Happens

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<p>On May 5, 2025, President Trump <a href="https://www.whitehouse.gov/presidential-actions/2025/05/regulatory-relief-to-promote-domestic-production-of-critical-medicines/" target="_blank" rel="noreferrer noopener">issued an executive order</a> aimed at increasing domestic medication production. In addition to removing regulatory barriers for domestic manufacturers, the order included an intention to conduct more unannounced inspections of overseas laboratories to match the level of scrutiny the country currently gives to domestic laboratories.</p>
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<p>Despite this new directive, “our dependency on foreign sources for pharmaceuticals is not expected to go down anytime soon,” says <a href="https://publichealth.jhu.edu/faculty/3523/mariana-p-socal" target="_blank" rel="noreferrer noopener">Mariana Socal</a>, M.D., Ph.D., an associate professor of health policy and management at Johns Hopkins Bloomberg School of Public Health.</p>
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<p>According to <a href="https://www.healthaffairs.org/doi/10.1377/hlthaff.2022.01120" target="_blank" rel="noreferrer noopener">a research article published in 2023</a>, 86% of active pharmaceutical ingredients (APIs) in U.S. medications were produced abroad, and conducting more surprise overseas laboratory inspections could help strengthen drug safety and quality. But it’s an effort the FDA has already been pursuing for years, with limited success.</p>
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<p><a href="https://www.tradestone-qa.com/about.html" target="_blank" rel="noreferrer noopener">Patrick Stone</a>, a former inspector for the Food and Drug Administration (FDA) who now advises manufacturers on inspection readiness, agrees the new proposal, while sound in principle, may come too late to make a meaningful difference. “This will help, but how many of them will they conduct?” he wrote in an email to MedShadow. “They conduct so few international inspections, it will take years to catch up.”</p>
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<h2 class="wp-block-heading">How Are Drug Manufacturing Labs Regulated by the FDA?</h2>
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<p>The FDA trains and employs <a href="https://medshadow.org/the-fda-has-failed-to-inspect-thousands-of-drug-manufacturing-labs/" target="_blank" rel="noreferrer noopener">inspectors who visit manufacturing labs in the U.S. and overseas</a>, and determines which labs to visit based on an internal risk assessment.</p>
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<p>Before visiting a lab, Stone explains, an inspector will familiarize himself with any complaints or issues reported to the FDA about the lab or its products and the outcomes of any previous inspections. Then, he’ll take time to learn about the products made at that facility: “How complicated is it to make? How dangerous is it at each step? If you miss a step or don’t do a step right, is it going to hurt someone?”</p>
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<p>For most inspections, an FDA investigator will spend two to five days at a facility. He’ll look around for obvious problems that could cause contamination, such as unsealed doors, bugs, and unsterile equipment. He’ll review the company’s protocols for ensuring drug quality and investigate whether employees are adequately trained on that protocol. At the end, he’ll compile a report for the FDA, and it’s up to the agency to decide how to proceed.</p>
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<p>For minor issues, the FDA may request voluntary corrective actions from the manufacturer. But for more serious problems, the agency can issue a Warning Letter, requiring the manufacturer to devise a plan to address deficiencies or risk an import ban.</p>
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<h2 class="wp-block-heading">Why Aren’t There More Unannounced Inspections Overseas?</h2>
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<p>While drug manufacturing began shifting overseas in the 1970s, the pace of expansion <a href="https://www.fda.gov/news-events/congressional-testimony/covid-19-and-beyond-oversight-fdas-foreign-drug-manufacturing-inspection-process-06022020#:~:text=This%20movement%20accelerated%20in%20the%202000s%2C%20but%20due%20to%20statutory%20mandates%20for%20biennial%20domestic%20inspections%20and%20limited%20staffing%2C%20FDA%E2%80%99s%20inspectorate%20remained%20focused%20on%20domestic%20manufacturing" target="_blank" rel="noreferrer noopener">accelerated in the early 2000s</a> as more laboratories opened in foreign countries. This escalation caused the FDA to fall behind with scheduled inspections.</p>
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<p>Making things even more difficult, the Government Accountability Office (GAO) has highlighted the agency’s inability to <a href="https://www.gao.gov/products/gao-25-106775#:~:text=What%20GAO%20Found,among%20its%20drug%20inspection%20workforce." target="_blank" rel="noreferrer noopener">hire and retain inspectors</a> — many of whom are poached by industry for higher wages and better work-life balance — in report after report <a href="https://www.gao.gov/products/gao-24-107359" target="_blank" rel="noreferrer noopener">starting in 2009.</a></p>
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<p>Even when FDA inspectors are available to travel abroad, conducting an ideal inspection presents significant challenges. In the U.S., an inspector shows up for a surprise visit at the laboratory and immediately begins a tour of the lab in its current state, explains Stone. That’s not always the case for inspections of foreign labs.</p>
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<p>“There’s multiple challenges in creating a proper environment for an unannounced inspection,” agrees Dr. Socal.</p>
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<p>In many countries,  aninspector needs a visa or a translator to travel to the foreign lab they hope to inspect. They have to make travel and hospitality arrangements in advance. Dr. Socal explains that when an inspector makes these plans, it’s possible that the details are shared with labs, allowing them to prepare for and expect an inspection. “This could possibly undermine the real surprise factor of such inspections,” she says, adding that it’s hard to quantify how often this might happen.</p>
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<h2 class="wp-block-heading">What Will the Executive Order on Surprise Inspections Do?</h2>
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<p>President Trump’s executive order directs FDA Commissioner Dr. Martin A. Makary to devise a plan to improve the inspections of overseas drug manufacturing labs. It notes the improvements “shall be funded by increased fees on foreign manufacturing facilities to the extent consistent with applicable law.”</p>
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<p>The executive order also directs Dr. Makary to publicly disclose the number of inspections conducted each year, broken down by country and manufacturer. This information is currently available online — though it is not easy to parse through — on the <a href="https://datadashboard.fda.gov/cder/cd/inspections.htm" target="_blank" rel="noreferrer noopener">FDA Inspections Data Dashboard</a> (an free account is required to access the information).</p>
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<p>Though the renewed focus on surprise inspections has drawn attention, it is not without precedent: At the end of 2022, <a href="https://www.congress.gov/bill/117th-congress/house-bill/2617#:~:text=(Sec.%203615)%20This%20section%20establishes%20a%20pilot%20program%20to%20increase%20unannounced%20surveillance%20inspections%20of%20foreign%20human%20drug%20establishments.%20The%20FDA%20shall%20evaluate%20the%20differences%20between%20such%20inspections%20on%20foreign%20and%20domestic%20establishments." target="_blank" rel="noreferrer noopener">Congress directed the FDA</a> to establish a pilot program to increase unannounced inspections of foreign drug manufacturing labs.</p>
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<p>It’s unclear whether that program made a difference.</p>
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<p>As of 2022, 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.</p>
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<p>Whether this executive order leads to improved drug safety may not be immediately apparent, either, but if the <a href="https://datadashboard.fda.gov/cder/cd/inspections.htm" target="_blank" rel="noreferrer noopener">FDA’s data dashboard</a> remains up to date, the impact could become clearer once inspection figures for 2025 — both domestic and foreign — are available.</p>
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