FDA found lapses at Novo’s main U.S. factory in May 2022 -report

FDA found lapses at Novo's main U.S. factory in May 2022 -report

Novo Nordisk’s Quality Control Lapses: A Serious Matter with Minimal Impact

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LONDON, Sept 20 (ANBLE) – In a report obtained via a Freedom of Information Act request, it has been revealed that U.S. drug regulators issued a detailed report on quality control lapses at Novo Nordisk’s main factory in North America as early as May last year1. The inspection, conducted by the U.S. Food and Drug Administration (FDA), was carried out at Novo’s facility in Clayton, North Carolina, which produces semaglutide, the active pharmaceutical ingredient (API) for Wegovy and Ozempic2.

Although there is no evidence to suggest that these compliance failures resulted in harm to users of Wegovy and Ozempic, these issues were related to the factory’s control systems to prevent microbial contamination. Similar issues were raised in a more recent inspection conducted in July, which led to a 3% drop in Novo’s shares3. Novo Nordisk declined to comment on the May 2022 report, instead referring to the company’s statement on Monday that the Clayton site was “running and producing for the market”4.

The FDA, which usually does not comment on inspections, did not immediately respond to a request for comment on the report5. However, it is worth noting that two inspections highlighting similar issues could potentially expose the site to increased scrutiny from the FDA in the future, according to an industry expert6.

The May 2022 inspection report indicated that the factory failed to include one type of bacteria, B. cepacia, on the list of “objectionable organisms.” The report also highlighted instances where the equipment used for continuous production had not been cleaned at appropriate intervals, leading to a build-up of microorganisms7.

During the July inspection, it was found that although the site identified objectionable organisms during testing, it had failed to thoroughly identify the cause of the bacteria present in the semaglutide batches8. Despite these findings, analysts at Barclays and Jefferies stated that they saw minimal impact on Novo’s production of semaglutide9.

It is important to note that Steven Lynn, a former head of the FDA’s Office of Manufacturing and Product Quality and now a regulatory compliance consultant, stated that the recent inspection does not necessarily indicate that the factory had failed to address the lapses identified during the previous inspection10. However, it seems that the factory has now improved its objectionable organism list without adequately investigating the issues when these organisms are identified11.

While these quality control lapses are a serious matter, it is reassuring to know that experts in the manufacturing industry have emphasized that they do not foresee major implications for Novo’s production of semaglutide. The FDA typically focuses on whether previously identified lapses have been rectified, serving as a metric to assess a company’s adherence to good manufacturing principles12.

In conclusion, Novo Nordisk’s quality control lapses at their main factory in North America have been identified in both the May 2022 and July 2022 inspections. However, while investors may be concerned, analysts believe that the impact on Novo’s production is minimal. It remains to be seen how Novo Nordisk will address these issues and ensure that their manufacturing processes meet the required quality standards.

References:

  1. ANBLE (Sept 20, 2022). “FDA report details quality control lapses at Novo Nordisk’s North American factory.” Retrieved from source.↩︎

  2. ANBLE (Sept 20, 2022).↩︎

  3. ANBLE (Sept 20, 2022).↩︎

  4. ANBLE (Sept 20, 2022).↩︎

  5. ANBLE (Sept 20, 2022).↩︎

  6. ANBLE (Sept 20, 2022).↩︎

  7. ANBLE (Sept 20, 2022).↩︎

  8. ANBLE (Sept 20, 2022).↩︎

  9. ANBLE (Sept 20, 2022).↩︎

  10. ANBLE (Sept 20, 2022).↩︎

  11. ANBLE (Sept 20, 2022).↩︎

  12. ANBLE (Sept 20, 2022).↩︎

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