The US Food and Drug Administration has released details of the warning letter sent to Zydus Cadila Healthcare following an inspection at its Indian drug manufacturing facility in Moraiya, Ahmedabad, from 22 April to 3 May 2019.
FDA Holds Zydus Cadila Responsible For ‘Repeat Violations’
Agency May Withhold Approval Of Abbreviated New Drug Applications
The FDA has published details of a warning letter summarizing significant violations of cGMP regulations to Zydus Cadila. The agency called the company’s prior response “insufficient.”
