The US Food and Drug Administration (FDA) completed its inspection of Lupin’s Goa plant on September 19 with “seven observations,” the pharmaceutical stated in a regulatory filing.
The examination took place over the course of 12 days, finishing on September 18, according to Lupin. The FDA’s findings are significant since the facility had already received a warning letter from the American regulatory authority.
“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.