Lupin Receives One USFDA Observation for Goa Facility
Mumbai: Lupin Limited has received one observation in a Form 483 issued by the United States Food and Drug Administration (USFDA) following an inspection of its manufacturing facility in Goa, India, conducted from October 19 to October 23, 2026.
According to the company, the US FDA concluded its inspection of the Goa manufacturing facility on October 23, 2026, and issued a Form 483 containing one observation. The company stated that it would address the observation and submit its response to the US FDA within the stipulated timeframe.
Lupin further stated that it remained committed to maintaining compliance with current Good Manufacturing Practice (cGMP) standards across all its facilities. The company did not provide further details regarding the specific nature of the observation in its announcement.
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