 "Zydus Lifesciences gets 4 observations from USFDA for Gujarat plant")
Zydus Lifesciences on Wednesday said the US health regulator has issued a Form-483 with four observations following the inspection of its Ahmedabad-based SEZ Onco Injectable manufacturing plant.
The US Food and Drug Administration (USFDA) conducted the cGMP (Current Good Manufacturing Practice) inspection at the facility from March 18-27, 2024, the company said in a regulatory filing.
The inspection closed with four observations, it added.
There were no data integrity-related observations, the drug firm said.
Zydus will closely work with the USFDA to address the observations, it added.
Shares of the company ended 1.82 per cent lower at Rs 999.60 apiece on BSE.