The USFDA conducted an inspection at the manufacturing facility located at SEZ, Ahmedabad of Zydus Animal Health and Investments Limited (a wholly owned subsidiary of Zydus Lifesciences Limited) from 23rd to 29th September, 2022.
This is a new dedicated manufacturing facility for the animal health business which will cater to US and other regulated markets. The inspection was a Pre-Approval Inspection (PAI) and ended with two observations. None of these observations were related to data integrity.
The company will address the observations within a stipulated timeline working with the regulators.