USFDA issues Form-483 with 10 observations to Lupin's Pithampur plant

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Drug firm Lupin on Thursday 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 US FDA 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.