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

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 the 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, 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.