The Foreign Inspection Gap: FDA GMP Oversightof U.S. Drug Imports, 2014-2024

The Foreign Inspection Gap: FDA GMP Oversightof U.S. Drug Imports, 2014-2024 | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article The Foreign Inspection Gap: FDA GMP Oversightof U.S. Drug Imports, 2014-2024 George Kwiecinski, Kevin Yuan This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-7849765/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 03 Mar, 2026 Read the published version in Journal of Pharmaceutical Innovation → Version 1 posted You are reading this latest preprint version Abstract Background: With the globalization of the pharmaceutical industry, the majority of active pharmaceutical ingredients and finished drug products entering the U.S. market originate from overseas manufacturing sites. From 2014 to 2024, FDA‐conducted foreign Good Manufacturing Practice (GMP) inspections have fallen sharply. This divergence underpins the FDA’s recent shift toward unannounced foreign facility inspections and underscores the need to modernize global oversight. Objectives: This study examines how trends in FDA inspection quality relate to increasing import volumes of drugs into the United States by analyzing FDA-issued observations since 2014 and assessing the impact of escalating imports on inspection practices and enforcement. Methods: U.S. FDA inspections and import volumes of drugs and drug products to the United States were assessed. Ratios of import quantities and inspections were used to evaluate the FDA's effectiveness in enforcing inspections abroad, as drug imports increased from 2014 to 2024. Results: Higher import volumes were accompanied by a drop in inspection frequency from 2014 to 2019. For every additional billion dollars of drug imports to the United States, there were ~23 fewer inspections conducted during 2014–2019. Additionally, while import volumes increased for leading import nations, inspections declined for the same period in most circumstances. Conclusion: The globalization of API sourcing, MRA-driven inspection gaps, incentive-driven host country behaviors, and COVID-era constraints help demonstrate the precedent for the FDA’s new unannounced visit mandate. The FDA should continue modernizing and developing its foreign inspection framework and selection process, while formulating additional tools and policies to ensure inspection quality. FDA inspections Foreign inspections Pharmaceutical imports GMP compliance Mutual Recognition Agreements (MRA) Full Text Additional Declarations Competing interest reported. The author is employed by a company specializing in FDA data analytics, which may be perceived as a potential competing interest. Cite Share Download PDF Status: Published Journal Publication published 03 Mar, 2026 Read the published version in Journal of Pharmaceutical Innovation → Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-7849765","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":531941205,"identity":"b277b873-fe4b-43c9-a53f-67dadf9eabc8","order_by":0,"name":"George Kwiecinski","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAABEElEQVRIie3RMUvDQBgG4C+cnMuh64VY+hcSPjgQDh39Gw2BTMG5g4SAkG66WhT6FxwdIwdxuR/g2r1CAyJ10X5xUJSedBS8dzg+Xnh4hwPw8fnDiYHRO6KD71YfTVBtT0SzLfk85Oh3Mjw5b7vnMWD8wO6X87sS98KnNhKgB7fNZpLYNrs+sKBiwzOZWqN4dJoTydFJrgpkYQ1aGaEgrRvNo0IRMamTzBZE3nqy/0Kk1Dy0PXl3kqEUGHQVKFrhRJjiUvSkcZJY5BmDVuKx4SjT2iAXBR7exBlOXSsTY4LVmU6ml2bevdZlMpvY5HExPhpcuFaoZwLkt3JHfv3ThpWKPm31o2RLN/Dx8fH5h1kDTydU+VKOZUAAAAAASUVORK5CYII=","orcid":"","institution":"New York University","correspondingAuthor":true,"prefix":"","firstName":"George","middleName":"","lastName":"Kwiecinski","suffix":""},{"id":531941206,"identity":"6946a1b0-96c6-41cb-addc-cc088f58d317","order_by":1,"name":"Kevin Yuan","email":"","orcid":"","institution":"University of Wisconsin–Madison","correspondingAuthor":false,"prefix":"","firstName":"Kevin","middleName":"","lastName":"Yuan","suffix":""}],"badges":[],"createdAt":"2025-10-13 13:53:23","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-7849765/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-7849765/v1","draftVersion":[],"editorialEvents":[{"content":"https://doi.org/10.1007/s12247-026-10406-3","type":"published","date":"2026-03-03T15:58:07+00:00"}],"editorialNote":"","failedWorkflow":false,"files":[{"id":94124890,"identity":"a80187b9-3334-427f-98de-d1491cb0ae51","added_by":"auto","created_at":"2025-10-22 16:02:08","extension":"json","order_by":0,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":4545,"visible":true,"origin":"","legend":"","description":"","filename":"8314cc305939479894a3a4b50229c867.json","url":"https://assets-eu.researchsquare.com/files/rs-7849765/v1/f292957aac780a21eca25efd.json"},{"id":104251896,"identity":"819ca708-9a13-4b42-8a71-0402f2dc7f34","added_by":"auto","created_at":"2026-03-09 16:15:52","extension":"pdf","order_by":1,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":622795,"visible":true,"origin":"","legend":"","description":"","filename":"TheFDAForeignInspectionGap20142024.pdf","url":"https://assets-eu.researchsquare.com/files/rs-7849765/v1_covered_ec4ae187-4a02-4b74-b4ba-3316fc36d458.pdf"}],"financialInterests":"Competing interest reported. The author is employed by a company specializing in FDA data analytics, which may be perceived as a potential competing interest.","formattedTitle":"\u003cp\u003eThe Foreign Inspection Gap: FDA GMP Oversightof U.S. Drug Imports, 2014-2024\u003c/p\u003e","fulltext":[],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":true,"hasManuscriptDocX":false,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":true,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":true,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"FDA inspections, Foreign inspections, Pharmaceutical imports, GMP compliance, Mutual Recognition Agreements (MRA)","lastPublishedDoi":"10.21203/rs.3.rs-7849765/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-7849765/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003eBackground: With the globalization of the pharmaceutical industry, the majority of active pharmaceutical ingredients and finished drug products entering the U.S. market originate from overseas manufacturing sites. From 2014 to 2024, FDA‐conducted foreign Good Manufacturing Practice (GMP) inspections have fallen sharply. This divergence underpins the FDA’s recent shift toward unannounced foreign facility inspections and underscores the need to modernize global oversight.\u0026nbsp; \u0026nbsp;\u0026nbsp;\u0026nbsp; \u0026nbsp;\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eObjectives: This study examines how trends in FDA inspection quality relate to increasing import volumes of drugs into the United States by analyzing FDA-issued observations since 2014 and assessing the impact of escalating imports on inspection practices and enforcement.\u003c/p\u003e\n\u003cp\u003eMethods: \u0026nbsp; U.S. FDA inspections and import volumes of drugs and drug products to the United States were assessed. Ratios of import quantities and inspections were used to evaluate the FDA's effectiveness in enforcing inspections abroad, as drug imports increased from 2014 to 2024.\u0026nbsp;\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eResults:\u0026nbsp; Higher import volumes were accompanied by a drop in inspection frequency from 2014 to 2019. For every additional billion dollars of drug imports to the United States, there were ~23 fewer inspections conducted during 2014–2019. Additionally, while import volumes increased for leading import nations, inspections declined for the same period in most circumstances.\u0026nbsp;\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eConclusion: The globalization of API sourcing, MRA-driven inspection gaps, incentive-driven host country behaviors, and COVID-era constraints help demonstrate the precedent for the FDA’s new unannounced visit mandate. The FDA should continue modernizing and developing its foreign inspection framework and selection process, while formulating additional tools and policies to ensure inspection quality.\u0026nbsp;\u003c/p\u003e","manuscriptTitle":"The Foreign Inspection Gap: FDA GMP Oversightof U.S. Drug Imports, 2014-2024","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-10-22 16:02:04","doi":"10.21203/rs.3.rs-7849765/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"11198ea3-d82c-4208-829b-7955c76c4a21","owner":[],"postedDate":"October 22nd, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2026-03-09T16:11:25+00:00","versionOfRecord":{"articleIdentity":"rs-7849765","link":"https://doi.org/10.1007/s12247-026-10406-3","journal":{"identity":"journal-of-pharmaceutical-innovation","isVorOnly":false,"title":"Journal of Pharmaceutical Innovation"},"publishedOn":"2026-03-03 15:58:07","publishedOnDateReadable":"March 3rd, 2026"},"versionCreatedAt":"2025-10-22 16:02:04","video":"","vorDoi":"10.1007/s12247-026-10406-3","vorDoiUrl":"https://doi.org/10.1007/s12247-026-10406-3","workflowStages":[]},"version":"v1","identity":"rs-7849765","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-7849765","identity":"rs-7849765","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}