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.
The FDA earlier questioned the process when it denied approval of the product, the spokesperson said. The company remains in contact with ...
