FDA 483 - BioMarin International Limited

BioMarin International Ltd.'s drug substance manufacturing facility in Ringaskiddy, Ireland, was cited for three observations. The inspection revealed inadequate investigation of deviations, specifically regarding bioburden excursions and the lack of proper corrective and preventive actions for sanitization. Additionally, microbial control of a manufacturing skid was found to be inadequate, with spore-forming bacteria identified in multiple lots, and there was no protocol to verify the effectiveness of sanitization solutions.