FDA 483 - Aizant Drug Research Solutions Private Ltd. - July 31, 2026

An FDA inspection of Aizant Drug Research Solutions Private Ltd. in Hyderabad, India, a finished human drug product manufacturer, revealed three significant observations. Deficiencies were noted in equipment cleaning and maintenance procedures, including scratched and dented product contact surfaces. The firm also failed to conduct complete identity testing for incoming drug product components and cleaning materials. Additionally, the facility's building was not maintained in a good state of repair, with rust and water staining observed directly above open in-process products.