US FDA raises concerns about Lupin's Goa plant
The Indian drug and active pharmaceutical ingredient (API) confirmed its facility in Goa had been visited by the US Food and Drug Administration (FDA) on March 15 in its response to a BSE request for more information prompted by reports in the Indian press.
In a statement the firm said: “The US FDA inspected Lupin’s Goa facility last week and cited nine observations” adding that “the observations are on aspects such as inadequacy and adherence to SOPs.”
Lupin also said it is putting together a plan to address the FDA’s observations.
The Goa plant makes finished drug formulations – including oral and injectable drug products – for the US market.
According to a post on the CDSCO website the Goa facility is certified as good manufacturing practice (GMP) compliant by the World Health Organisation (WHO).
