Health
Novo’s Main Ozempic Plant Cited for Quality Lapses by FDA
- Issues related to production of once-weekly insulin, Novo says
- Novo races to boost supplies of diabetes, obesity blockbusters
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Novo Nordisk A/S was cited for quality lapses at a drug production plant in Denmark that makes the hit medicines Ozempic and Wegovy.
The plant in Kalundborg, Denmark lacked information intended to show that water used in drug production was adequately controlled for certain microorganisms, according to a US Food and Drug Administration inspection report from March. The manufacturing process was being used at the plant to make a once-weekly form of insulin, a Novo spokesperson said.