FDA 483 - Micro Labs Limited - May 30, 2025

An FDA inspection of Micro Labs Limited, a drug product manufacturer in Verna, Goa, India, revealed significant deficiencies in their manufacturing process controls and quality system. The firm failed to establish adequate control procedures for monitoring manufacturing processes and did not thoroughly review unexplained discrepancies or out-of-specification results with scientific justification. These findings indicate a lack of robust quality oversight in drug production.