An Analysis of FDA Warning Letter Citations from 2019-2023

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.