Lupin Receives U.S. FDA Warning Letter for Somerset Facility
The Indian drugmaker said it received a warning letter from the U.S. FDA for the company’s Somerset facility in New Jersey.
(Bloomberg) -- Indian drugmaker Lupin Ltd. said it received a warning letter from the U.S. FDA for the company’s Somerset facility in New Jersey after inspections last year.
The warning letter came after inspections of the plant by the regulator from September to November last year, the company said in a stock exchange filing.
Lupin said that it believed the letter won’t have any impact on supplies or existing revenues from operations of the facility, and it was committed to addressing concerns raised by the FDA. The company also said it will comply with good manufacturing practice standards.
Lupin had previously disclosed receiving 13 observations from the FDA based on the inspections. The drugmaker had also received a letter warning of possible regulatory action from the FDA in 2019 after a 2018 inspection of the same plant.
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