{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,11]],"date-time":"2026-09-11T16:11:40Z","timestamp":1789143100486,"version":"build-2803163510"},"reference-count":15,"publisher":"Oxford University Press (OUP)","issue":"9","license":[{"start":{"date-parts":[[2026,8,27]],"date-time":"2026-08-27T00:00:00Z","timestamp":1787788800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100014848","name":"Arnold Ventures","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100014848","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100007188","name":"Uniformed Services University of the Health Sciences","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100007188","id-type":"DOI","asserted-by":"publisher"}]},{"name":"Center for Health Services Research"},{"DOI":"10.13039\/100000005","name":"U.S. Department of Defense","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000005","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100009898","name":"Defense Health Agency","doi-asserted-by":"publisher","award":["HU00012520014"],"award-info":[{"award-number":["HU00012520014"]}],"id":[{"id":"10.13039\/100009898","id-type":"DOI","asserted-by":"publisher"}]},{"name":"Johns Hopkins University Nexus Research"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,9,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>The U.S. Food and Drug Administration (FDA) inspections are central to oversight of the pharmaceutical manufacturing base, but long-term inspection and reinspection patterns remain incompletely characterized.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>We analyzed 25 629 FDA Drug Quality Assurance inspections conducted from October 2008 through December 2025. We described annual, regional, and outcome patterns. Linking inspections to facilities, we examined time to reinspection according to the outcome of preceding inspections.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Annual Drug Quality Assurance inspections declined from 1594 in 2019 to 461 in 2020 and increased to 1218 in 2025. The United States remained the largest single region of inspection activity, but its contribution declined over time. The proportion of favorable inspection outcomes (no action indicated\u2014NAI) decreased from 40.0% before the pandemic to 19.3% during and 23.7% after. Unfavorable outcomes (voluntary action indicated\u2014VAI\u2014and official action indicated\u2014OAI) increased accordingly. The mean reinspection interval was 3.18 years after NAI, 2.96 after VAI, and 2.12 after OAI (P &amp;lt; .001). Median times were 4.08, 3.51, and 3.02 years, respectively.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>FDA inspection activity had not returned to prepandemic levels by 2025. Unfavorable inspection outcomes were associated with earlier reinspection, consistent with risk-responsive oversight. However, the available data cannot establish whether follow-up was timely or adequate.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/haschl\/qxag229","type":"journal-article","created":{"date-parts":[[2026,8,27]],"date-time":"2026-08-27T06:44:05Z","timestamp":1787813045000},"source":"Crossref","is-referenced-by-count":0,"title":["FDA drug quality assurance inspections: frequency, outcomes, and time to reinspection, 2008-2025"],"prefix":"10.1093","volume":"4","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-3634-9453","authenticated-orcid":false,"given":"Yunxiang","family":"Sun","sequence":"first","affiliation":[{"name":"Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health , Baltimore, MD 21205 ,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2564-4577","authenticated-orcid":false,"given":"Jeromie","family":"Ballreich","sequence":"additional","affiliation":[{"name":"Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health , Baltimore, MD 21205 ,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joy","family":"Acha","sequence":"additional","affiliation":[{"name":"Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health , Baltimore, MD 21205 ,","place":["United States"]},{"name":"Johns Hopkins Carey Business School, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD 21202 ,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0003-4933-7966","authenticated-orcid":false,"given":"Riya","family":"Modi","sequence":"additional","affiliation":[{"name":"Department of Biomedical Engineering, Johns Hopkins Whiting School of Engineering , Johns Hopkins Bloomberg School of Public Health, Baltimore, MD 21218 ,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mohammad Ali","family":"Alamdar Yazdi","sequence":"additional","affiliation":[{"name":"Johns Hopkins Carey Business School, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD 21202 ,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5256-1446","authenticated-orcid":false,"given":"Maqbool","family":"Dada","sequence":"additional","affiliation":[{"name":"Johns Hopkins Carey Business School, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD 21202 ,","place":["United States"]},{"name":"Johns Hopkins School of Medicine , Johns Hopkins Bloomberg School of Public Health, Baltimore, MD 21205 ,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9248-5153","authenticated-orcid":false,"given":"Tinglong","family":"Dai","sequence":"additional","affiliation":[{"name":"Johns Hopkins Carey Business School, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD 21202 ,","place":["United States"]},{"name":"Johns Hopkins School of Nursing , Johns Hopkins Bloomberg School of Public Health, Baltimore, MD 21205 ,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1845-1523","authenticated-orcid":false,"given":"Gerard","family":"Anderson","sequence":"additional","affiliation":[{"name":"Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health , Baltimore, MD 21205 ,","place":["United States"]},{"name":"Johns Hopkins School of Medicine , Johns Hopkins Bloomberg School of Public Health, Baltimore, MD 21205 ,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9459-4898","authenticated-orcid":false,"given":"Mariana P","family":"Socal","sequence":"additional","affiliation":[{"name":"Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health , Baltimore, MD 21205 ,","place":["United States"]},{"name":"Johns Hopkins Carey Business School, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD 21202 ,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2026,8,27]]},"reference":[{"key":"2026091111365110200_qxag229-B1","author":"Center for Drug Evaluation and Research"},{"key":"2026091111365110200_qxag229-B2","author":"Office of the Commissioner"},{"key":"2026091111365110200_qxag229-B3","author":"Office of Regulatory Affairs"},{"key":"2026091111365110200_qxag229-B4","author":"Office USGA"},{"issue":"12","key":"2026091111365110200_qxag229-B5","doi-asserted-by":"publisher","first-page":"1758","DOI":"10.1377\/hlthaff.2023.00686","article-title":"FDA global drug inspections: surveillance of manufacturing establishments remains well below Pre-COVID-19 levels","volume":"42","author":"Cuddy","year":"2023","journal-title":"Health Aff."},{"key":"2026091111365110200_qxag229-B6","author":"FDA Dashboards\u2014Inspections"},{"key":"2026091111365110200_qxag229-B7","author":"Office of Regulatory Affairs"},{"key":"2026091111365110200_qxag229-B8","author":"Office of Regulatory Affairs"},{"key":"2026091111365110200_qxag229-B9","author":"Office of the Commissioner"},{"key":"2026091111365110200_qxag229-B10","author":"Office of the Commissioner"},{"key":"2026091111365110200_qxag229-B11","author":"Office of Inspections and 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