FDA reinspects Novo Nordisk's Indiana plant, finds mammalian hair and roof leaks compromising drug sterility

Novo Nordisk's manufacturing facility in Indiana, acquired from Catalent, has undergone a second FDA reinspection after earlier concerns.

The April inspection revealed mammalian hair in finished drug batches and water leaks in the roof, both of which could jeopardize product sterility.

The findings highlight ongoing contamination challenges at the site, prompting further regulatory scrutiny and potential corrective actions.

The issues add pressure on Novo Nordisk to address quality control at the plant to avoid disruptions to its insulin and other product supplies.