FDA 483 - BioMarin Pharmaceuticals Inc. - August 19, 2024

An FDA 483 inspection of BioMarin Pharmaceuticals Inc. at their Novato, CA facility, conducted from July 30 to August 19, 2024, revealed an observation concerning inadequate documentation of sanitization procedures. The primary issue was the lack of documented assurance that sanitizers and sporocides were consistently applied for established minimum contact times in cGMP manufacturing and quality control Laminar Air Flow Hoods (LAFs) and Biological Safety Cabinets (BSCs). Specifically, logbooks for LAFs lacked initial and end contact times for sanitizing agents, and in QC laboratories, documented timeframes between sanitization and bioburden sample testing for BSCs were found to be less than the minimum required by procedure. This observation, issued under Section 704(b) of the Federal Food, Drug and Cosmetic Act, indicates potential non-compliance with current Good Manufacturing Practices (cGMP) related to aseptic technique and environmental control. BioMarin Pharmaceuticals Inc. is required to implement corrective actions to ensure proper documentation and adherence to established contact times for all sanitization processes, thereby preventing potential contamination and ensuring product quality and safety.