FDA 483 - AnaZeal Analyticals & Research Pvt Ltd - February 19, 2025

AnaZeal Analyticals & Research Pvt Ltd, a laboratory in Navi Mumbai, India, was inspected by the FDA from February 17-19, 2025. The inspection revealed deficiencies in the firm's quality control unit, specifically concerning incomplete root cause analysis and risk assessment in deviation and complaint investigation reports. This indicates a significant issue with the firm's quality system and its ability to thoroughly investigate and address quality events.