Zydus Lifesciences has received a Warning Letter from the USFDA relating to its Injectables manufacturing facility at Jarod near Vadodara. The Warning Letter summarizes violations with respect to Current Good Manufacturing Practice (cGMP) regulations. The Warning Letter does not contain any data integrity related violations.
Earlier on July 18, 2024, the company’s Jarod facility had received official action indicated (OAI) status by the USFDA . This site was inspected by USFDA from April 15 to April 23, 2024. The contents of the Warning Letter will be made public by the USFDA in due course.
Zydus Lifesciences (formerly known as Cadila Healthcare) is an India-based pharmaceutical company.