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 issued a Form 483 outlining the necessary changes to address the violations.
The facility had reported cases of contamination by "atypical extrinsic particles," including cat and human hair found in vial stoppers, and pest infestations in classified areas.
This OAI designation affects 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: Novo Nordisk's Bloomington plant faces FDA issues.
- Facility received OAI designation from FDA
- Contamination and compliance issues reported
- Partners Scholar Rock and Regeneron affected