Zydus gets four observations from USFDA for Moraiya unit

Zydus Lifesciences on Friday said the US health regulator has issued four observations after inspecting its Moraiya Ahmedabad based manufacturing plant.The US Food and Drug Administration USFDA inspected the facility from July 26 to August 5.

Zydus Lifesciences on Friday said the US health regulator has issued four observations after inspecting its Moraiya (Ahmedabad) based manufacturing plant.

The US Food and Drug Administration (USFDA) inspected the facility from July 26 to August 5. ''The inspection concluded with four Form 483 observations. None of the observations was related to data integrity,'' the drug maker said in a regulatory filing.

The company will address the observations within the stipulated timeline, it added.

As per the US health regulator, an FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Act.

Shares of the company on Friday ended 2.02 per cent down at Rs 357.20 apiece on the BSE.