FDA 483 - ZYDUS LIFESCIENCES LIMITED - August 05, 2022

ZYDUS LIFESCIENCES LIMITED, a finished drug manufacturer in Ahmedabad, India, received a Form 483 with four observations. The inspection revealed significant issues including repeated failures to thoroughly investigate out-of-specification results and implement corrective actions, as well as a lack of adequate written procedures for process controls, hold times, and sampling. These deficiencies indicate a systemic breakdown in quality assurance and process control for commercialized drug products.