Lupin gets seven USFDA observations for Goa facility

Written By :  Ruchika Sharma
Medically Reviewed By :  Dr. Kamal Kant Kohli
Published On 2025-11-22 06:13 GMT   |   Update On 2025-11-22 06:13 GMT
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Mumbai: Lupin has announced that the company has received seven observations from the U.S. Food and Drug Administration (USFDA) after an inspection at its manufacturing facility located in Goa, India.

As per the BSE filing, the inspection was conducted from November 10 to November 21, 2025 and closed with the issuance of a Form-483 with seven 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.

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"We will address the observations and respond to the U.S. FDA within the stipulated timeframe. We are committed to be compliant with CGMP standards across all our facilities," Lupin stated.

Lupin Limited is a global pharmaceutical company headquartered in Mumbai, India, with products distributed in over 100 markets. Lupin specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. The company has a strong position in India and the U.S. across multiple therapy areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women's health. Lupin has 15 state-of-the-art manufacturing sites and 7 research centers globally.

Read also: Lupin secures S&P Global ESG Score of 91 for 2025

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