Micro Labs Limited – FDA 483, Aug 22, 2025

Micro Labs Limited, an Active Pharmaceutical Ingredient Manufacturer in Bangalore, India, was cited for four significant observations during an FDA inspection. The firm demonstrated deficiencies in investigating out-of-specification results and implementing timely corrective actions, managing major facility changes, and ensuring accurate microbiological data through adequate procedures. Additionally, the inspection revealed a lack of control over its computerized water system, including shared access and unreviewed alarm audit trails, indicating a moderate level of non-compliance with good manufacturing practices.