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 FDA issued a Form 483 outlining the violations, which include unaddressed cases of contamination by "atypical extrinsic particles," such as cat and human hair found in vial stoppers, and reports of pest infestations in classified areas.
The fallout is impacting partners Scholar Rock and Regeneron, who have pending regulatory applications tied to the facility.
The OAI designation means that a facility is in "an unacceptable state of compliance."
Author's summary: FDA issues OAI designation to Novo Nordisk's plant.
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