USFDA issues 5 observations for Lupin Nagpur facility
Mumbai: Lupin has recently announced that the US Food and Drug Administration has concluded a Pre-Approval Inspection (PAI) with five observations at the company's Nagpur Unit-2 injectable manufacturing facility.
The inspection was conducted from October 17, 2022 to October 29, 2022.
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.
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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