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USFDA conducts inspection at Lupin’s manufacturing facility in Goa

The Inspection was conducted from November 10, 2025 to November 21, 2025 and closed with the issuance of a Form-483 with seven observations

United States Food and Drug Administration (USFDA) has conducted an inspection at Lupin’s manufacturing facility located at Goa, India. The Inspection was conducted from November 10, 2025 to November 21, 2025 and closed with the issuance of a Form-483 with seven observations.

The company will address the observations and respond to the USFDA within the stipulated timeframe. It is committed to be compliant with CGMP standards across all its facilities.  

Lupin is an innovation led transnational pharmaceutical company producing, developing and marketing a wide range of branded and generic formulations, biotechnology products and active pharmaceutical ingredients (APIs) globally.