FDA 483 - Serum Institute of India Pvt. Ltd. - April 19, 2022

The FDA inspection of Serum Institute of India Pvt. Ltd. in Manjari Bk., Pune, revealed significant deficiencies in their manufacturing operations. Key issues included widespread good documentation practices and data integrity failures, inadequate process validation, and a lack of robust systems for deviation reporting, investigations, and timely corrective actions. These findings indicate serious concerns regarding the firm's quality control and compliance with regulatory standards.