Lupin Limited on Thursday said the US health regulator has issued a Form-483 with ten observations after inspecting its Pithampur Unit-2 manufacturing facility, via an exchange filing.
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 the regulatory filing.
"We are addressing the observations comprehensively and will work with the US FDA to resolve these issues at the earliest," it added.
According to the USFDA, a Form 483 is given to a company's management following an inspection if the investigator found any situations that, in its opinion, may constitute violations of the Food, Drug, and Cosmetic (FD&C) Act and associated Acts.
At Lupin's manufacturing site in Mandideep, the USFDA issued Form-483 in November of last year with eight observations for the product and raw material production centres combined.
Following a pre-approval inspection of its Unit-2 injectable production facility in Nagpur, the US health regulator issued Form-483 with five observations in October 2022, according to the company.
