Analyzing FDA Form 483 Data of 2023: Identifying Trends and Areas of Concern in Regulatory Compliance

• ABM Mahfuz ul Alam*

Abstract

This study scrutinizes a dataset originating from the FDA's Form 483 to discern nuanced trends and areas of concern within the realm of regulatory compliance. The dataset encompasses 1983 observations categorized across ten subparts, allowing for a quantitative evaluation of prevalent issues in each section. Subparts J, F, and I emerge prominently, collectively constituting 53.8% of all observations, indicating their significance in regulatory oversight. The analysis provides specific quantitative values that shed light on the severity and repetition of observed issues. Subpart J stands out with the highest single repetition, registering at 114, suggesting persistent challenges that warrant close attention. Furthermore, the sum of the top three observations, totaling 1067 across Subparts J, F, and I, highlights the cumulative impact of these areas on overall compliance. This quantitative approach contributes to a nuanced understanding of compliance challenges, allowing stakeholders to strategically allocate resources. The study emphasizes the need for targeted interventions, particularly in Subparts J, F, and I, where elevated counts and percentages signal potential systemic issues. The concentration of observations in the top three subparts underscores the importance of collaborative efforts among stakeholders to proactively address and rectify these challenges, fostering sustained improvements in regulatory compliance and upholding the integrity of FDA-regulated products.

Keywords

FDA Form 483; Data Integrity, Data Governance, ALCOA+, Subpart B - Organization and Personnel, Subpart C - Buildings and Facilities, Subpart D - Equipment, Subpart E - Control of Components and Drug Product Containers and Closures, Subpart F - Production and Process Controls, Subpart G - Packaging and Labeling Control, Subpart H - Holding and Distribution. Subpart I - Laboratory Controls, Subpart J - Records and Reports, 21 CFR Part 211

Ahead of Print Date : 2024-05-22