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

During an inspection conducted from May 26 to May 30, 2025, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Andelyn Biosciences, Inc., a drug substance manufacturer located in Columbus, OH. The inspection revealed significant deficiencies across several critical areas impacting product quality.

The observations highlighted inadequate quality oversight, including insufficient review of production records, leading to multiple re-dispositions of product lots. The company's deviation management system was found to be ineffective, failing to properly identify, investigate, and implement corrective and preventive actions for manufacturing deviations and persistent human errors. Documentation practices were also cited as inadequate, with issues such as uncontrolled spreadsheets, incorrect document versioning, and incomplete records. Additionally, personnel training was deemed insufficient.

Further issues included a deficient environmental monitoring program, lacking validation for viable sampling and proper particulate monitoring. Qualifications for manufacturing cleanrooms were inadequate, with concerns regarding alarm delays and incomplete evaluation of all supplied areas. Critical utility monitoring was also deficient, lacking proper qualification and bioburden control for product contact liquids and incubator water. The disinfectant efficacy studies were found to be insufficient, not demonstrating effectiveness against viral contaminants or for all representative surfaces. Lastly, procedures for handling out-of-specification results lacked sufficient detail for comprehensive investigations.

These observations indicate potential non-compliance with regulatory manufacturing standards essential for ensuring drug substance quality. Andelyn Biosciences, Inc. is required to provide a written response to the FDA detailing comprehensive corrective actions taken or planned to address each observation and prevent recurrence.