Zydus Lifesciences recently informed the exchanges that the USFDA issued a warning letter regarding its injectables manufacturing facility in Jarod, near Vadodara. The warning letter details violations of Current Good Manufacturing Practice (cGMP) regulations. The warning letter does not include any data integrity breaches.
In the filing, the company further shared, “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 said that it will take all required actions to work with the USFDA on the quickest remediation of the above facility.
