Last Updated on October 9, 2024 by The Health Master
New Delhi: Drug firm Lupin said the US health regulator has issued a Form-483 with ten observations after inspecting its Pithampur Unit-2 manufacturing facility.
The US Food and Drug Administration (USFDA) inspected the plant from March 21 to March 29, 2023.
The inspection closed with issuance of a Form-483 with ten observations, Lupin said in a regulatory filing.
“We are addressing the observations comprehensively and will work with the USFDA to resolve these issues at the earliest,” it added.
As per the USFDA, a Form 483 is issued to a firm’s management at the conclusion of an inspection when the investigator has observed any conditions that in its judgement may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
In November last year, USFDA had issued Form-483 with eight observations each for product and raw material production centres at Lupin’s Mandideep-based manufacturing facility.
In October 2022, the drugmaker 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.
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