USFDA issues Form-483 with 8 observations to Lupin’s drug, API production facilities in Mandideep plant

Drug maker Lupin on Thursday said the US health regulator has issued Form-483 with eight observations each for product and raw material production centres at its Mandideep-based manufacturing facility. As per the US Food and Drug Administration (USFDA), Form 483 is issued to a firm’s management at the conclusion of an inspection, when the investigator has observed any conditions that may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.

The USFDA had inspected the Mandideep Unit-1 facility in Madhya Pradesh from November 14, 2022, to November 23, 2022, the Mumbai-based drug maker said in a regulatory filing.

“The inspection of the facility closed with issuance of a Form-483 with eight observations each for the drug product facility and active pharmaceutical ingredient (API) facility at the site,” it added.

The company is committed to addressing the observations and will work with the US health regulator to resolve the issues at the earliest, Lupin said.
On October 30, the drug maker announced that the US health regulator has issued Form-483 with five observations following a pre-approval inspection of its Unit-2 injectable manufacturing facility at Nagpur.

Shares of Lupin closed 0.11 per cent down at Rs 718 apiece on the BSE.

(With inputs from health)