Last Updated on October 9, 2024 by The Health Master
Pharmaceuticals firm Lupin Ltd said 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.
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 US Food and Drug Administration (USFDA) inspected the Nagpur Unit-2 injectable manufacturing facility from October 17, 2022, to October 29, 2022, the company said in a regulatory filing.
“The inspection closed with the issuance of a Form-483 with five observations,” it added.
The inspection was a pre-approval inspection of the injectable facility, Lupin said. “
We are committed to addressing the observations at the earliest, and gaining approval for injectable manufacturing for the US,” the company added.
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