FDA 483 - ProRx LLC - September 19, 2025

ProRx LLC received a Form 483 with seven observations, primarily concerning significant deficiencies in aseptic processing, environmental monitoring, and quality control for sterile drug products. The inspection revealed failures to thoroughly investigate microbial contamination events, inadequate aseptic techniques, and insufficient validation of sterilization processes. Additionally, the firm's quality unit lacked proper oversight, and drug product labels were found to be non-compliant with federal regulations.