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.
LONDON, Sept 20 - U.S. drug regulators issued a report detailing quality control lapses at Novo Nordisk's
There is no evidence that compliance failures flagged in the report known as a Form 483 resulted in harm to users of Wegovy and Ozempic. A Form 483 is a type of agency report containing "observations" that FDA inspectors "deem to be objectionable". One industry expert, who spoke on condition of anonymity due to the sensitivity of the matter, said similar issues at two inspections some time apart could expose the site to increased scrutiny from the FDA going forward.
The report included a second manufacturing lapse: "Failure to clean equipment at appropriate intervals" to prevent build-up of microorganisms on equipment. The report noted that the equipment in question was used for "continuous production" of batches of API.
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