Concerns about acceptable production practices at Catalent's syringe filling facility is the reason why Novo Nordisk is now only expected to be able to fully meet Wegovy demand in the second half of 2022, according to media Bioprocess International.
Catalent confirms that an inspection by the US Food and Drug Administration (FDA) resulted in an FDA Form 483, which is issued to a firm's management following an inspection during which objectionable conditions have been observed.
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