Novo Nordisk Indiana plant faces FDA re-inspection after hair found in drugs and roof leaks threaten sterility

Novo Nordisk's fill‑finish facility in Bloomington, Indiana underwent a follow‑up FDA inspection in April. The agency reported mammalian hair in finished drug containers and identified water leaks in the roof that could compromise product sterility.

The findings follow earlier contamination concerns at the same site, which have kept the plant under heightened regulatory scrutiny. FDA officials have warned that any breach of sterility could trigger broader actions, including production pauses.

The company has said it is addressing the issues and working with the regulator to remediate the facility. Continued problems could affect the supply of its insulin products and draw investor attention to the operational risks at the plant.