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

An FDA inspection of Serum Institute of India Pvt. Ltd., a biological manufacturer in Manjari Bk., revealed significant deficiencies across multiple areas. Findings included poor documentation practices, issues with analytical methods and reference standards, deviations from approved manufacturing processes, and inadequate investigations and environmental monitoring in aseptic processing areas. These observations indicate a need for comprehensive improvements in quality systems and manufacturing controls.