FDA 483 - Andelyn Biosciences, Inc. - May 30, 2025

Amelyn Biosciences, Inc. in Columbus, OH, was cited for multiple significant deficiencies during an FDA inspection, primarily concerning inadequate quality oversight, environmental controls, and facility qualification for drug substance manufacturing. The observations highlight systemic failures in deviation management, documentation, training, utility monitoring, and disinfectant efficacy, indicating a lack of robust control over critical processes and potential risks to product quality.