{"title":"An Analysis of FDA Warning Letter Citations from 2019-2023","authors":"George Kwiecinski","doi":"10.1007/s12247-024-09879-x","DOIUrl":null,"url":null,"abstract":"<div><h3>Purpose</h3><p>This study investigates trends in the issuance of FDA warning letters from 2019 to 2023. The paper aims to assess past and present FDA statements of inspection efficiency from a quantitative and qualitative perspective.</p><h3>Methods</h3><p>An analytical approach combining regex filtering and web scraping was developed to log citations of law within FDA warning letters. The process included identifying recurring keywords for categorization by keyword, department, and legal reference.</p><h3>Results</h3><p>From 2019 to 2023, the FDA went from issuing a warning letter 2.98 times per 100 inspections to 4.27 times per 100 inspections, a 43% increase in warning letters issued per 100 inspections.</p><h3>Conclusions</h3><p>From 2019 to 2023, the FDA issued more warning letters more frequently when compared to inspection volume, reallocating resources and priorities throughout the COVID-19 pandemic.</p></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"19 6","pages":""},"PeriodicalIF":2.7000,"publicationDate":"2024-11-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s12247-024-09879-x.pdf","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Pharmaceutical Innovation","FirstCategoryId":"3","ListUrlMain":"https://link.springer.com/article/10.1007/s12247-024-09879-x","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
引用次数: 0
Abstract
Purpose
This study investigates trends in the issuance of FDA warning letters from 2019 to 2023. The paper aims to assess past and present FDA statements of inspection efficiency from a quantitative and qualitative perspective.
Methods
An analytical approach combining regex filtering and web scraping was developed to log citations of law within FDA warning letters. The process included identifying recurring keywords for categorization by keyword, department, and legal reference.
Results
From 2019 to 2023, the FDA went from issuing a warning letter 2.98 times per 100 inspections to 4.27 times per 100 inspections, a 43% increase in warning letters issued per 100 inspections.
Conclusions
From 2019 to 2023, the FDA issued more warning letters more frequently when compared to inspection volume, reallocating resources and priorities throughout the COVID-19 pandemic.
期刊介绍：
The Journal of Pharmaceutical Innovation (JPI), is an international, multidisciplinary peer-reviewed scientific journal dedicated to publishing high quality papers emphasizing innovative research and applied technologies within the pharmaceutical and biotechnology industries. JPI''s goal is to be the premier communication vehicle for the critical body of knowledge that is needed for scientific evolution and technical innovation, from R&D to market. Topics will fall under the following categories:
Materials science,
Product design,
Process design, optimization, automation and control,
Facilities; Information management,
Regulatory policy and strategy,
Supply chain developments ,
Education and professional development,
Journal of Pharmaceutical Innovation publishes four issues a year.
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