FDA 483 - Biocon Limited - July 20, 2022

An FDA inspection of Biocon Limited's API manufacturing and method validation laboratory in Pashamylaram, Telangana, India, revealed significant deficiencies. Observations included issues with data integrity and control mechanisms for raw data, inadequate monitoring of critical storage parameters for materials and APIs, and failures to follow established procedures for employee training and vendor qualification. These findings indicate a lack of robust quality control and adherence to GMPs.