By: IPP Bureau
Last updated : August 31, 2024 10:21 am
The company will take all necessary steps to work with USFDA towards earliest remediation of the above facility
Zydus Lifesciences Ltd has received a Warning Letter issued by 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. This is further to our communication dated July 18, 2024, about Jarod facility receiving OAI status by the USFDA. This site was inspected by USFDA from April 15 to April 23, 2024. The contents of the Warning Letter shall be made public by the USFDA in due course.
The company will take all necessary steps to work with USFDA towards earliest remediation of the above facility.