FDA 483 - Strides Pharma Science Limited - May 24, 2019

An FDA inspection of Strides Pharma Science Limited in Bangalore, Karnataka, India, a manufacturer of finished drugs, revealed significant deficiencies in quality control and manufacturing processes. The firm failed to conduct complete investigations into out-of-specification results and unexplained discrepancies, and lacked adequate control procedures for monitoring manufacturing processes and environmental conditions. Additionally, laboratory controls for media acceptance were found to be deficient.