Zydus Lifesciences Ltd on Friday (August 30, 2024) said the U.S. health regulator has issued a warning letter for its injectables manufacturing facility at Jarod near Vadodara, Gujarat over violations of manufacturing regulations.
The warning letter issued by the US Food and Drug Administration (USFDA) relating to its injectables manufacturing facility at Jarod does not contain any data integrity-related violations, Zydus Lifesciences said in a regulatory filing.
It summarises violations with respect to Current Good Manufacturing Practice (cGMP) regulations, the company added.
“The contents of the warning letter shall be made public by the USFDA in due course,” the company said, adding that it would take all necessary steps to work with USFDA towards the earliest remediation of the above facility.
In July this year, the company stated that the USFDA had classified the Jarod facility as official action indicated (OAI) subsequent to an inspection by the health regulator from April 15 to April 23, 2024.
As per the USFDA, OAI implies that the regulator may withhold approval of any pending product applications or supplements filed from such facility till the outstanding observations related to non compliance with manufacturing norms laid down by it.
