The US drug regulator inspected the injectable facility from February 24 to March 10, 2022.
The inspection closed with three observations, the drug firm said in a regulatory filing.
“We are confident of addressing and resolving the issues to the satisfaction of USFDA. We remain committed to building a quality culture across our entire manufacturing network, and are committed to remain compliant with high standards of good manufacturing practices across our network,” Zydus Lifesciences said.
USFDA issues its observations through Form 483 at the conclusion of an inspection if the investigators have observed any conditions that may violate current good manufacturing practices.