FDA 483 - Micro Labs Limited - August 22, 2025

Micro Labs Limited, an Active Pharmaceutical Ingredient Manufacturer in Bangalore, India, was cited with four observations during an FDA inspection. The firm failed to adequately investigate out-of-specification results and implement timely corrective actions, and its change controls for a major facility modification lacked comprehensive quality impact assessments. Additionally, the firm lacked adequate procedures for microbiological data quality control and failed to establish proper controls for its computerized water system, including alarm review.