FDA 483 - Merck Biodevelopment

Merck BioDevelopment in Martillac, France, a drug substance manufacturing facility, was cited for significant quality system deficiencies. The inspection revealed inadequate investigations into deviations, particularly concerning visible particles in drug substance intermediates, and incomplete documentation for various deviations, including a lack of root cause analysis and preventive actions. Additionally, temporary equipment storage conditions were not properly assessed for microbial contamination risks, leading to bioburden excursions.