USFDA Inspects Lupin's Pithampur Unit-2, Issues 10 Observations
On Thursday, Mumbai-based Lupin pharmaceuticals informed that the top regulatory body USFDA issued a Form-483 with 10 observations for its second manufacturing unit at Pithampur, Madhya Pradesh.
USFDA issues Form-483 when an investigator has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Act.
"USFDA inspected Lupin’s Pithampur Unit-2 manufacturing facility from March 21 to March 29, 2023. The inspection closed with issuance of a Form-483 with ten observations," the pharma major said in a regulatory filing.
The pharma firm further said it is addressing the observations comprehensively and will work with the USFDA to resolve these issues as soon as possible.
"We uphold quality and compliance with utmost importance across all our facilities. This may kindly be 'considered as a disclosure pursuant to Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015," the company said in a regulatory statement.
Lupin's stock closed 1.28 per cent higher at Rs 652.45 on BSE.
