USFDA concludes inspection at Lupin's Goa facility with one observation

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Inspection conducted from October 19-23, 2026

By PTI

Updated - October 25, 2026 at 09:33 AM. | New Delhi

Lupin says will address the observation and respond to the USFDA within the stipulated timeframe. | Photo Credit: DANISH SIDDIQUI

Drugmaker Lupin said on Saturday that the US health regulator concluded an inspection at its Goa manufacturing facility with one observation.

The inspection by the US Food and Drug Administration (USFDA) was conducted from October 19-23, 2026, Lupin said in a regulatory filing.

An FDA Form 483 is issued to a firm's management at the conclusion of an inspection when investigators observe conditions that, in their judgment, may constitute violations of the Food, Drug, and Cosmetic Act and related standards.

"We will address the observation and respond to the USFDA within the stipulated timeframe. We are committed to being compliant with CGMP standards across all our facilities," the company stated in the disclosure.

Published on October 25, 2026

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