By admin 
Zydus Life on Friday, August 30, said it has received a warning letter from the United States Food and Drug Administration (USFDA) for its injectables manufacturing facility in Jarod near Vadodara, Gujarat.
The warning letter summarises violations regarding the current good manufacturing practice regulations, the company said in a stock exchange filing. It added that the warning letter does not contain any violations related to data integrity.
On July 18, 2024, the pharma company had stated that the Jarod facility had received ‘Official Action Indicated’ (OAI) classification by the USFDA. The site was inspected from April 15 to April 23, 2024. The USFDA will make the contents of the warning letter public in due course, Zydus Life said.
OAI classification means that violations found on-site require further administrative sanctions and mandatory corrective actions.
“The company will take all necessary steps to work with the USFDA towards earliest remediation of the above facility,” the company said.
Zydus Life shares were trading 1.55% up at ₹1,149.55 apiece at 2.05 pm on Friday, August 30. The stock has gained 64.32% this year, so far.