Regulatory Data Insights and Methods of Extraction and Analysis: Poster Presented at PDA Week 2025.

Abstract

This study investigates trends in FDA warning letter issuance between 2019 and 2023, focusing on the agency's efficiency and evolving priorities during this period. By analyzing both quantitative and qualitative data, the research highlights an increase of 43% in warning letters issued per 100 inspections. Using a novel approach combining regex filtering and web scraping, this presentation examines recurring keywords, department-specific citations, and legal references. The analysis aims to help attendees understand how structured data from regulatory agencies can be harnessed to improve compliance and inspection readiness.