Lupin gets 8 USFDA observations for Mandideep facility
Mumbai: Lupin has recently announced that the US Food and Drug Administration (USFDA) has concluded an inspection with eight observations each for product and raw material production centers at its Mandideep-based manufacturing facility.
An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
The USFDA inspected Lupin's Mandideep Unit-1 facility from November 14, 2022 to November 23, 2022.
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"The inspection of the facility closed with issuance of a Form-483 with eight observations each for the Drug Product facility and API facility at the site. We are committed to addressing the observations and will work with the USFDA to resolve these issues at the earliest. We do not believe that this will have an impact on disruption of supplies or the existing revenues from operations of this facility," the company stated in a BSE filing.
"We uphold quality and compliance issues with utmost importance and remain committed to be compliant with cGMP quality standards across all our facilities," Lupin stated.
Medical Dialogues team had earlier reported that Lupin Limited had received the Establishment Inspection Report (EIR) after the closure of the U.S. FDA inspection of its Mandideep Unit II facility, classifying the inspection as Voluntary Action Indicated.
Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle-East regions.
The Company specializes in the cardiovascular, anti-diabetic, and respiratory segments and has a significant presence in the anti-infective, gastrointestinal (GI), central nervous system (CNS), and women's health areas.
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