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

Analyn Biosciences, Inc. in Columbus, OH, received a Form 483 citing significant deficiencies in quality oversight, environmental monitoring, and utility management during the manufacture of drug substance. The inspection revealed inadequate deviation management, poor documentation practices, and insufficient training, alongside issues with cleanroom qualification and disinfectant efficacy studies. These findings indicate a lack of robust controls necessary to ensure product quality and compliance.