Lupin gets 2 USFDA observations for Somerset facility

Written by Ruchika Sharma Published On 2023-01-16T13:15:54+05:30 | Updated On 16 Jan 2023 1:15 PM IST

Mumbai: Lupin has announced that the company has received two observations from the US Food and Drug Administration (USFDA) at the closure of inspection at the company's manufacturing facility in Somerset, New Jersey, U.S.A.

USFDA inspected Lupin's said manufacturing facility from January 2, 2023 to January 13, 2023.

The inspection closed the with issuance of a Form-483 with two observations.

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.

"We are addressing the observations comprehensively and will work with the USFDA to resolve these issues at the earliest. We uphold quality and compliance with utmost importance and are committed to be compliant with CGMP standards across all our facilities," the firm stated in a BSE filing.

Medical Dialogues Team had earlier reported that Lupin had received the Establishment Inspection Report (EIR) from USFDA for its Somerset, NJ manufacturing facility, after the inspection of the facility in March 2022.

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, gastro-intestinal (GI), central nervous system (CNS), and women’s health areas. The company invested 8.7% of its revenue in research and development in FY22.

Lupin has 15 manufacturing sites, 7 research centers, and has been consistently recognized as a ‘Great Place to Work’ in the Biotechnology & Pharmaceuticals sector

Read also: Lupin unveils fixed-dose triple drug combination DIFIZMA DPI for inadequately controlled asthma

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Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751