New Delhi, Oct 30 (PTI) Pharmaceuticals firm Lupin Ltd on Sunday 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.

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The US Food and Drug Administration (USFDA) had 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 issuance of a Form-483 with five observations," it added.

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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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