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Regulatory Data, Transformed. Allowing you to use market data to make safer decisions in the quality and regulatory environment for all critical manufacturing. Access FDA warning letters and 1.5M+ regulatory data points.
GKS Newsletter
GKS Newsletter
George K.'s LinkedIn
George K.'s LinkedIn
Zephaniah O.'s LinkedIn
Zephaniah O.'s LinkedIn
Research Paper - FDA Warning Letter Analysis
Research Paper - FDA Warning Letter Analysis
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.
GKS Calendar
GKS Calendar
March 2026. Explore the Quality Intelligence Library in Calendar view from Global Key Solutions.
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