Pharmaceuticals firm Lupin Ltd. on Sunday said the U.S. 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 U.S. Food and Drug Administration, 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 Act and related Acts.
The U.S. Food and Drug Administration had inspected the Nagpur Unit-2 injectable manufacturing facility from Oct. 17, 2022 to Oct. 29, 2022, the company said in a regulatory filing.
"The inspection closed with 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 U.S.," the company added.
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