U.S. FDA issues two observations to Zydus’ oncology injectable plant in Ahmedabad

U.S. Food and Drug Administration (FDA) has issued two observations to the oncology injectable plant of Zydus in Ahmedabad.

The observations were issued following a GMP follow-up inspection of the facility in SEZ 1, near Matoda from June 9-18. They were not related to data integrity. The company will closely work with the U.S. FDA to address and respond to the observations in an expeditious manner, Zydus said on Wednesday.