Strides Pharma Science Limited – FDA 483, 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.
ID · 6aba0508-6d58-45c8-abe2-72447d775be9
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