Zydus hit with trio of FDA observations at Indian injectables plant



India’s Zydus Lifesciences is in the FDA’s crosshairs once again, this time for a trio of unnamed violations at an injectables facility.


Following an FDA inspection that wrapped up this week, Zydus, formerly known as Cadila Healthcare, was hit with a trio of agency observations at one of its Indian manufacturing facilities. The regulator issued the write-up to Zydus’ injectables plant in Jarod, Gujarat, India, which it inspected between Feb. 24 and March 10.


In a corporate communique issued Thursday, Zydus said it was confident about “addressing and resolving the issues to the satisfaction of the USFDA,” without clarifying what those issues were.


The company didn’t immediately respond to Fierce Pharma’s request for comment on the nature of the FDA’s critiques.


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