India’s Lupin, whose manufacturing network racked up a warning letter and at least four Form 483s last year, has gotten off to a regulatory running start in 2020 with an early Form 483 from the FDA.
The drugmaker alerted investors of the filing on the weekend after the inspection but gave few details. The Form 483, which the FDA posted (PDF) Tuesday showed Lupin’s API plant in Andhra Pradesh was cited following an inspection that wrapped up January 17.
According to the five observations in the highly-redacted document, the FDA said the plant failed to identify the critical process parameters for APIs and intermediates. Inspectors said that some materials from suppliers were not tested for identity and purity and the sampling that was done fell short of FDA guidance. Finally, the FDA said that to the master batch records are made on a computer controlled by the production department and not quality assurance.
While the shortcomings were not unlike those observed at many plants, the findings added to a swelling file of issues at Lupin’s production facilities. Lupin has acknowledged that “US compliance issues,” are among factors taking a toll on its finances.
The drugmaker has taken steps to strengthen its balance sheet by unloading its Japanese operations last fall. It sold the sterile manufacturing assets of its Kyowa operation to United Arab Emirates-based Neopharma. It followed that up with the sale of the rest of the Kyowa Pharmaceutical Industry operations to a Japanese private equity fund in a deal that it expected would net it about $300 million. The sale included manufacturing facilities in Sanda and Tottori, Japan and a R&D center at Osaka.
While the sale was positioned as a way for the drugmaker to tidy up its balance sheet, it contributed to a net loss of Lupin in the second quarter.