FDA 483 - Syngene International Ltd. - February 20, 2025

An FDA inspection of Syngene International Ltd. in Bengaluru, India, revealed significant deficiencies in their API, Drug Substance, and Finished Drug Product manufacturing operations. Observations included inadequate vendor qualification for critical consumables, a deficient environmental monitoring program, and failures in investigating nonconformances. Additionally, issues were noted with the security and management of controlled documents and the cleanability of classified manufacturing areas.