The United States’ Food and Drug Administration (FDA) has concluded its inspection of the Goa-based facility of Lupin with “seven observations”, the drugmaker said in a regulatory filing on September 19.
The inspection was carried out over a period of 12 days, ending on September 18, Lupin said. The observations made by the US FDA assume significance as the plant had earlier received a warning letter from the American regulatory body.
“We wish to inform you that the U.S. FDA has concluded an inspection at our Goa facility in India. The inspection was carried out from September 6, 2021 to September 18, 2021, and closed with seven observations,” Lupin said.
The company added it was confident of addressing the observations “satisfactorily”.
Lupin is “committed to be compliant with Good Manufacturing Practice standards across all our facilities”, added the regulatory filing, which was issued in pursuant to the SEBI (Listing Obligations and
Disclosure Requirements) Regulations, 2015.
Notably, Lupin’s Goa site, along with Unit 2 manufacturing plant in Pithampur, Indore had received US FDA’s warning letter in November 2017.Internet Explorer Channel Network