FDA 483 - CTX Lifesciences Private Limited - September 02, 2022

CTX Lifesciences Private Limited, an API manufacturer in Surat, India, received a Form 483 with seven observations highlighting significant deficiencies in their quality system. Issues included failures in quality unit responsibilities, inadequate discrepancy reviews, poor computer system controls, and insufficient test method validation. Additionally, improper equipment cleaning and design, along with non-contemporaneous batch record completion, were cited.