USFDA issues Form 483 with 8 observations to Lupin

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

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USFDA Form 483

Last Updated on November 26, 2022 by The Health Master

New Delhi: Drug maker Lupin said the US health regulator has issued Form 483 with eight observations each for product and raw material production centers 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 the issuance of 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.

Lupin 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 percent down at Rs 718 apiece on the BSE.

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