Zydus Life Gets Warning Letter From US FDA Over Violations In Injectables Plant
However, the letter did not contain any data integrity related violations, the company said.
Source: Envato
Zydus Lifesciences Ltd. received a warning letter issued by the United States Food and Drug Administration with respect to its injectables manufacturing facility at Jarod near Vadodara.
The warning letter detailed violations with respect to current good manufacturing practice regulations, the company said in an exchange filing. However, the letter did not contain any data integrity-related violations, the filing said.
"This is further to our communication dated July 18, 2024, about Jarod facility receiving 'Official Action Indicated' status by the USFDA. This site was inspected by USFDA from April 15 to April 23, 2024," the company said.
The firm said that the contents of the warning letter will be made public by the USFDA in due time.
It also expressed plans to take necessary steps to work with the USFDA towards "earliest remediation" of the facility.
Shares of Zydus Lifesciences Ltd. closed 0.18% higher at Rs 1,113.50 apiece on the BSE, compared to a 0.01% decline in the BSE Sensex.
