In October, Cooper engineering students George Kwiecinski and Zephaniah Odidika attended the Biopharmaceutical Manufacturing Preparedness (BioMaP) Consortium Fall 2024 Industry Day held in Bethesda, Maryland. The event was notable for showcasing innovative research and providing opportunities for collaboration across the drug and vaccine manufacturing supply chain.

During the conference, George Kwiecinski presented his research, titled “An Analysis of FDA Warning Letter Citations from 2019-2023.” His study investigates trends in the issuance of FDA warning letters over a five-year period, offering valuable insights into inspection efficiency and legal compliance in the biopharmaceutical industry.

More information about George’s research paper can be found here. 

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 keyworkds 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 23% increase in warning letters issued per 100 inspections.

Conclusion: 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.