Zydus Lifesciences Ltd on Wednesday (March 27) said the US Food and Drug Administration (FDA) recently concluded an inspection at its SEZ onco injectable manufacturing plant in Ahmedabad.
"We wish to inform that the USFDA conducted an inspection at the SEZ Onco Injectable manufacturing plant at Ahmedabad. This cGMP USFDA inspection was conducted from March 18th to March 27th, 2024," Zydus Lifesciences said in a regulatory filing
The inspection, which took place between March 18-27, resulted in the identification of four observations.
There were no observations related to data integrity, which is often a significant concern in such inspections, Zydus said. In response to the findings, Zydus Lifesciences has committed to working closely with the FDA to address and resolve the observations.
Shares of Zydus Lifesciences Ltd ended at ₹1,002.40, down by ₹14.65, or 1.44%, on the BSE.
