USFDA inspection: Lupin gets warning letter for Tarapur facility
Mumbai: Pharma major, Lupin, has announced that the Company has received a warning letter from the US Food and Drug Administration (USFDA) for the Company's Tarapur, Maharashtra (India) facility.
The USFDA had inspected the Lupin Tarapur site from March 22, 2022 to April 4, 2022.
"The Company does not believe that the warning letter will have an impact on disruption of supplies or the existing revenues from operations of this facility," Lupin stated in a BSE filing.
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"We are committed to addressing the concerns raised by the U.S. FDA and will work with the U.S. FDA to resolve these issues at the earliest. We uphold quality and compliance issues with utmost importance and remain committed to be compliant with CGMP quality standards across all our facilities," Lupin added.
Medical Dialogues team had earlier reported that Lupin had received four observations from the US Food and Drug Administration (USFDA) at the conclusion of an inspection at the company's Tarapur manufacturing facility.
Read also: Lupin gets 4 USFDA observations for Tarapur facility
The Company specializes in the cardiovascular, anti-diabetic, and respiratory segments and has a significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS), and women's health areas.
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