Novo Nordisk's Bloomington Plant Receives FDA OAI Designation
The Novo Nordisk facility in Bloomington, IN, has been issued an Official Action Indicated (OAI) label by the FDA due to contamination and compliance issues.
The plant, formerly owned by Catalent, was inspected by the FDA in July and received the OAI designation on October 9. The FDA stated that the facility is in "an unacceptable state of compliance" and issued a Form 483 outlining the necessary changes.
The issues at the plant include unaddressed cases of contamination by "atypical extrinsic particles," such as cat and human hair found in vial stoppers, as well as reports of pest infestations in classified areas.
The fallout from this issue is impacting partners Scholar Rock and Regeneron, who have pending regulatory applications tied to the facility.
The facility is in "an unacceptable state of compliance."
Author's summary: Novo Nordisk's Bloomington plant faces FDA issues.
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