FDA 483 - Micro Labs Limited - June 30, 2026

An FDA inspection of Micro Labs Limited, a sterile drug manufacturer in Bengaluru, Karnataka, revealed significant deficiencies across its quality and production systems. Observations included inadequate investigations into recurring container closure defects, an insufficient environmental monitoring program, and a flawed visual inspection process for sterile drug products. Further issues were noted in maintaining aseptic conditions, cleaning and sanitization practices, and the monitoring of critical utility systems, indicating a broad failure to ensure drug product quality and purity.