FDA 483 - Strides Pharma Science Limited - December 05, 2022

Strides Pharma Science Limited in Bangalore, India, received a Form 483 with three observations related to significant deficiencies in their quality control and manufacturing processes. The inspection revealed failures in laboratory control mechanisms, including improper chromatographic peak integration, inadequate investigation of out-of-specification/out-of-trend results, and insufficient analytical method validation and transfer. Additionally, the firm lacked robust written procedures for production and process controls, leading to OOS results and inadequate handling of affected batches.