On June 13, the drug maker Lupin received a warning letter from the USFDA for the company’s Somerset facility in New Jersey. The USFDA on a inspection of Lupin Somerset Site from September 10, 2020 to November 5, 2020, had issued 13 observations. Somerset site had also received a warning letter in 2019 after an inspection in 2018 of the same plant.
The USFDA normally issues a warning letter if it finds any deficiencies of goods manufacturing parties. The warning letter restricts new approvals filed from that same site. Lupin in a statement made to the stock exchange’s said that it believes the letter won’t have any impact on the supplies or existing revenues.
Lupin also said that the company does not believe that there will be any impact on ‘disruption of supplies’ or the existing revenues from operations of this facility. “The facility contributes less than 5 per cent of it’s global revenues,” said Lupin.
The Somerset facility manufacturers oral formulations, derma and controlled substances. The company said that they are committed to addressing the concerns raised by the USFDA and will work with the FDA and the New Jersey District to resolve the issues at the earliest.
The company is committed to adhere to good manufacturing practice standards across all their facilities, and also says to uphold quality and compliance issues with utmost importance.
Lupin has been under USFDA scanner over compliance issues. The Indore Unit-2, Goa and Mandideep Unit-1 are also been included in the warning letter.