The FDA has classified Novo Nordisk’s Bloomington, Indiana contract-manufacturing site as “official action indicated” (OAI) after inspection findings linked to complete response letters for drugs made at the facility. Novo Nordisk confirmed the designation and said it is engaging with the agency and customers while enhancing processes. STAT and company statements identified multiple quality issues uncovered during the inspection, and the action follows regulators’ escalation that has already delayed approvals for at least two partner companies. For biotech firms relying on third-party or recently acquired manufacturing capacity, the OAI designation signals a heightened regulatory tail risk for drug approval timelines and supply chains.