FDA 483 - Mankind Pharma Limited - April 13, 2023

An FDA inspection of Mankind Pharma Limited's Control Testing Laboratory in Gurugram, Haryana, India, revealed significant deficiencies in laboratory controls. The firm failed to conduct scientifically justified investigations for out-of-specification results and did not adequately qualify laboratory equipment and instruments for their intended use. These issues indicate a lack of robust quality control in their testing processes.