FDA 483 - Biocon Biosphere Limited - June 14, 2024

An FDA inspection of Biocon Biosphere Limited in Visakhapatnam, India, revealed significant deficiencies across three observations. The firm failed to establish adequate written procedures for production and process controls, including the use of unqualified equipment and exceeding hold times for in-process materials. Additionally, laboratory controls were found to be lacking scientifically sound test procedures, indicating a potential impact on drug product quality.