Novo Nordisk's Bloomington Plant Receives FDA OAI Designation
The Novo Nordisk facility in Bloomington, IN, has received an official action indicated (OAI) label from 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. According to the FDA, this designation means the facility is in "an unacceptable state of compliance."
A Form 483 was issued, outlining the violations and necessary changes. The facility had reportedly unaddressed cases of contamination by "atypical extrinsic particles," including cat and human hair found in vial stoppers, and pest infestations in classified areas.
The fallout 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 receives FDA OAI designation.
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