Analysis of FDA Data Integrity Violations Before and After the COVID-19 Pandemic: A Comparative Study Based on Warning Letters
The Pharmaceutical Society Of Korea, Yoseok Park, Kyenghee Kwon · Yakhak Hoeji · 2025
This study examines 1,766 FDA warning letters issued between 2016 and 2023, with a focus on how the COVID-19 pandemic impacted data integrity violations within the pharmaceutical and biotechnology sectors. By comparing the pre-pandemic period (2016~2019) to the post-pandemic period (2020~2023), the research identifies notable increases in violations related to contemporaneous recordkeeping, accountability, and data availability. These increases were largely driven by the rapid transition to remote work and global supply chain disruptions, which exposed key vulnerabilities in data management systems. The study organizes these violations according to the ALCOA and ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Completeness, Consistency, Endurance, and Availability). The pandemic significantly intensified FDA regulatory scrutiny, as more frequent and severe data integrity violations emerged, leading to stricter compliance requirements for pharmaceutical companies. In addition to analyzing the trends in FDA warning letters, the research also explores the broader implications for the South Korean pharmaceutical industry, highlighting the urgent need for companies to bolster their electronic data management systems, improve internal audit processes, and provide comprehensive staff training to align with global regulatory standards. Strengthening these areas is crucial for maintaining data integrity, ensuring regulatory compliance, and securing a competitive advantage in the international market. Ultimately, this study underscores the critical role of robust data management in a post-pandemic world, offering targeted recommendations to address the challenges exposed by the pandemic and ensuring that companies are well-equipped to meet the evolving demands of global pharmaceutical regulations.