FDA Classifies Novo Nordisk Plant OAI, Product Approval for Regeneron, Scholar Rock Stuck

Novo Nordisk’s Bloomington plant (FEI 3005949964, Catalent Indiana LLC) is classified OAI by USFDA in October, 2025. FDA had inspected the sterile formulation facility in June-July 2025 and made critical observations of cGMP deviations. The facility was acquired by Novo Nordisk from the CDMO major Catalent in December 2024.

Major cGMP violations observed by the FDA at the Catalent facility include deficient failure investigations on issues such as hair strands and particulates in sterile drug products, lapses in microbial / environmental monitoring, visual inspection, sterility assurance and media fill studies and failure to test high risk components like diethylene glycol (DEG) and ethylene glycol (EG). The site was inspected by USFDA investigators Joohi Castelvetere, Robert J.Ham, Martin M.Kimani and Shannon L.Maisano.

The regulatory issues of the site are impacting drug product applications and supplements of Pharma Firms like Scholar Rock and Regeneron. Scholar Rock’s drug application for the spinal muscular atrophy treatment Apitegromab was issued a complete response letter (CRL) by FDA in September 2025. Regeneron’s PAS (prior approval supplement) for the prefilled syringe version of eye disease treatment Eylea HD (aflibercept) injection was also issued a CRL by FDA in October 2025. Another regulatory application of Regeneron pending with FDA is the supplemental Biologics License Application (sBLA) for use of EYLEA HD as a treatment for macular edema, as per a Regeneron Media statement.

The CRLs are issued citing manufacturing issues and unresolved inspection findings at Catalent, but not specific to the production of the above drugs.

• Regeneron Press Statement (October, 2025)
• Scholar Rock statement on CRL for Apitegromab Biologics License Application (BLA) (September 2025)
• Qvents Post: FDA 483 to Catalent Indiana Flags Inadequate Investigation of Contaminants, Equipment Failure