Zydus Lifesciences Gets Two USFDA Observations for Ahmedabad Oncology Plant

Zydus Lifesciences Ltd. said the US Food and Drug Administration has issued two observations following a pre-approval inspection at its oncology manufacturing facility in Ahmedabad. The inspection, conducted from November 4 to November 7, was related to the company’s new isolator injectable line.

The company clarified in an exchange filing that the observations were not linked to data integrity issues.