By Maggie Fick LONDON (Reuters) - U.S. drug regulators issued a report detailing quality control lapses at Novo Nordisk's main factory in North America ...
By Maggie Fick LONDON - 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 theSaltWire's Atlantic regional weather forecast for September 20, 2023 | SaltWireLONDON - U.S.
The issues were with the factory's control systems to prevent microbial contamination, the same as those raised in the more recent inspection this July, which was first reported by financial news agency MarketWire and pushed Novo's shares down 3%.A spokesperson referred Reuters to the company's statement on Monday, in response to the FDA's report from its July inspection, that the Clayton site was"running and producing for the market".
The report from the May 2022 inspection shows that FDA officials found the factory had failed to include one type of bacteria, abbreviated as B. cepacia, on its list of"objectionable organisms". When inspectors returned to the facility in July, they found that although the site was identifying objectionable organisms during testing of batches of semaglutide API, it had failed to thoroughly identify the cause of the bacteria present in these batches.
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