U.S. drug regulators issued a report detailing quality control lapses at Novo Nordisk’s main factory in North America as early as May last year, according to the report obtained by Reuters via a Freedom of Information Act request.
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Reuters was not immediately able to authenticate the report. Novo Nordisk declined to comment on the report, but said in an emailed statement that the site was “running and producing for the market”.
The factory that fills the self-injection pens for booming weight-loss drug Wegovy has repeatedly breached U.S. sterile-safety rules in recent years and staff have failed to perform required quality checks, according to a Reuters review of regulatory documents.
The health regulator flagged application deficiencies related to the FDA’s pre-license inspection of the company’s third-party contract manufacturing firms.
U.S. drug inspectors recently recorded several new quality- control problems at an Eli Lilly and Co plant that is already the subject of a federal investigation over manufacturing lapses, according to a government report reviewed by Reuters.
