Zydus Lifesciences Ltd. said on Friday that the US Food and Drug Administration has issued a warning letter for its injectables manufacturing facility at Jarod near Vadodara in Gujarat over violations of manufacturing regulations.
The warning letter summarises violations with respect to Current Good Manufacturing Practice regulations and does not contain any data integrity-related violations, as per the exchange filing.
'"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 the USFDA towards the earliest remediation of the above facility.
Earlier on July 18, the US FDA had classified the Jarod facility as official action indicated status following an inspection by the health regulator from April 15 to April 23, 2024.
Shares of Zydus Lifesciences closed 0.35% lower at Rs 1,128.30 per share, compared to a 0.28% advance in the BSE Sensex.
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