Novo Nordisk's recently acquired manufacturing site in Bloomington, Indiana, has received an "Official Action Indicated" (OAI) classification from the U.S. Food and Drug Administration, signifying the agency's most serious post-inspection compliance designation. The OAI status, assigned after the FDA's July 2025 inspection, indicates the facility is in an unacceptable state of compliance and may require regulatory actions to address unresolved deficiencies, including contamination instances involving foreign particles, cat hair, bacteria, and pests.
The site, formerly owned by Catalent and acquired by Novo Nordisk in late 2024 for $16.5 billion, serves as a contract manufacturing location for biotechnology clients including Regeneron and Scholar Rock. Following the inspection, both companies experienced setbacks: Regeneron received a complete response letter for its blood cancer therapy odronextamab and reported delayed decisions on high-dose Eylea applications, while Scholar Rock’s spinal muscular atrophy drug apitegromab faced a rejection.
Novo Nordisk stated it is working closely with FDA and affected partners to resolve the issues and enhance quality processes, but analysts suggest continued delays for regulatory approvals and product launches tied to the facility are likely until compliance concerns are fully addressed
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