FDA 483 - Zydus Lifesciences Limited - March 20, 2023

Zydus Lifescience Limited, a drug product manufacturer in Ahmadabad, India, was cited for three significant issues during an FDA inspection. Observations included inadequate cleaning and maintenance of manufacturing equipment leading to potential cross-contamination, a failure to thoroughly review unexplained discrepancies in laboratory testing, and a lack of adequate oversight on the use of qualified reference standards and analytical method validations. These issues indicate serious deficiencies in quality control and manufacturing practices.