FDA 483 - Aizant Drug Research Solutions Private Ltd. - November 14, 2025

Aizant Drug Research Solutions Pvt., Ltd. in Hyderabad, India, was inspected by the FDA from November 10-14, 2025. The inspection revealed two significant observations related to laboratory control procedures and data integrity. Specifically, the firm failed to consistently follow its SOP for repeating subject samples and inaccurately reported freeze/thaw cycles during sample analysis.