USFDA Inspection Of Granules' Visakhapatnam Unit Concludes With Zero Observations

Granules India’s active pharmaceutical ingredients (API) manufacturing facility in Visakhapatnam, Andhra Pradesh, has completed a U.S. Food and Drug Administration (U.S. FDA) inspection, the company said on Friday.

The Unit IV facility located in Visakhapatnam has successfully completed the U.S. FDA’s pre-approval inspection and GMP audit from June 26-30 with zero [Form 483] observations, the company said.

It also said in the filing that its facility at Jeedimetla (Hyderabad) also completed the US FDA’s surveillance inspection.

From June 26, 2023, through June 30, 2023, there was an audit. The company stated in an exchange filing that the Unit IV plant in Visakhapatnam produces active medicinal ingredients.

Source: Media reports