FDA makes four Form 483 observations at Zydus Lifesciences facility

Zydus Lifesciences (formerly known as Cadila Healthcare) said that the US Food and Drug Administration (FDA) completed an inspection of its Moraiya manufacturing plant in Ahmedabad with four Form 483 observations.

The FDA inspection was held from 26 July and 5 August 2022.

Zydus Lifesciences said that none of the observations made by the FDA pertained to data integrity and that the company will address the potential regulatory violations within the stipulated timeline.

FDA makes four Form 483 observations at Zydus Lifesciences facility. Photo courtesy of Zydus Cadila.