USFDA closes inspection of Lupin's facility with zero 483 observations

Global pharma major Lupin announced that the United States Food and Drug Administration (USFDA) completed an inspection of its injectable facility in Nagpur, concluding with zero observations, according to the company’s regulatory filing on the Bombay Stock Exchange (BSE).

A Form 483 is issued by the USFDA to firm management at the conclusion of USFDA inspections when investigators observe conditions that, in their judgement, may constitute violations of the Food, Drug, and Cosmetic Act and other acts or regulations. Issuance of such observations indicates potential violations of regulatory significance.

The inspection of the Nagpur facility was carried out by the US drug regulator from June 10 to June 13, 2024.

The Nagpur inspection comes after the USFDA issued a Form 483 containing six observations after conducting a pre-approval inspection of Lupin's manufacturing facility in Somerset, New Jersey, in May 2024.

Earlier in April, the USFDA also conducted a good manufacturing practices (GMP) inspection of Lupin's active pharmaceutical ingredients (API) manufacturing facility located at Dabhasa.

Nilesh Gupta, managing director, Lupin, said that the company is pleased to have a successful outcome of the USFDA inspection at its Nagpur injectable facility with zero observations.

“This reflects our dedication to upholding the highest quality and compliance standards across our facilities,” he said.

Lupin is the third-largest pharmaceutical company in the US by prescription. The company invested 7.8 per cent of its revenue in research and development in FY24.

The company currently has fifteen manufacturing sites and seven research centres worldwide.

The company develops and commercialises a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the United States, India, South Africa, and across the Asia-Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.