483
Strides Pharma Science LimitedFDA 483 - Strides Pharma Science Limited - May 24, 2019
Record Details
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.
Open in Dashboard
ID · 6aba0508-6d58-45c8-abe2-72447d775be9