Zydus Lifesciences has received a Warning Letter issued by the US Food and Drug Administration for its Injectables manufacturing facility at Jarod near Vadodara, Gujarat.
The Warning Letter summarises violations concerning Current Good Manufacturing Practice (cGMP) regulations. The letter does not contain any data integrity-related violations.
Earlier, on July 18, the facility received an OAI status. The site was inspected by USFDA from April 15 to 23, 2024.