FDA hits Novo Nordisk Indiana site with ‘official action indicated’ letter

A former Catalent site in Bloomington, Indiana, acquired late last year by Novo Nordisk, continues to be plagued by regulatory problems. A spokesperson for the Danish drugmaker acknowledged in an emailed statement to Pharma Manufacturing that an FDA inspection at the site was classified last week by the agency with Official Action Indicated (OAI) status.

“We are in active dialogue with the FDA and our Contract Development and Manufacturing Organization (CDMO) customers about this matter,” the Novo Nordisk spokesperson said in the statement. “Ensuring we meet GMP (Good Manufacturing Practices) and Novo Nordisk quality standards is a top priority, and we are enhancing our processes and procedures as part of our commitment to continuous improvement.”

According to the FDA, the OAI classification indicates a facility is “in an unacceptable state of compliance” and may have been issued a Form FDA-483 or FDA-4056 at the conclusion of an inspection. STAT obtained a copy of the FDA inspection report in August and said “hair, pests, bacteria, and equipment failures” were among the concerns cited by the agency at the Bloomington site.

Pharma Manufacturing previously reported that the FDA issued a Complete Response Letter (CRL) to Regeneron on July 30 for its blood cancer therapy odronextamab application tied to the Bloomington site inspection. The facility handles the final stages of drug preparation and packaging for both odronextamab and eye disease drug Eylea HD.

In a Monday statement, Regeneron said it was notified by Catalent Indiana, LLC — part of Novo Nordisk — that the drugmaker received an OAI letter on Oct. 9 from the FDA, following a July general site inspection by the regulator.

Regeneron said there are two regulatory applications under review by the FDA including a Chemistry, Manufacturing and Controls (CMC) Prior-Approval Supplement (PAS) for the EYLEA HD (aflibercept) Injection 8 mg prefilled syringe device, and a supplemental Biologics License Application (sBLA) for the use of EYLEA HD as a treatment for macular edema following retinal vein occlusion (RVO) and for broadening the EYLEA HD dosing schedule to include every 4-week (monthly) dosing across approved indications.

“Catalent Indiana, LLC is the manufacturing filler included in the EYLEA HD Biologics License Application (BLA),” Regeneron said in its statement. “While Catalent Indiana, LLC continues to work with the FDA to resolve the outstanding issues, Regeneron is planning to submit an application to include an additional manufacturing filler in the EYLEA HD BLA within the next three months.”

Regeneron announced in August as part of its second-quarter 2025 financial results that the FDA on July 30 issued a CRL for its application for odronextamab, a bispecific antibody targeting CD20 and CD3 in relapsed/refractory follicular lymphoma after two or more lines of systemic therapy.

On Monday, Scholar Rock issued a statement that Novo Nordisk on Oct. 10 informed the company the agency has determined that the inspection classification is OAI. Last month, Scholar Rock announced that the FDA issued a CRL for its apitegromab BLA for the treatment of patients with spinal muscular atrophy, following an FDA Form 483 issued to Novo Nordisk.

“We continue to work closely with Novo Nordisk, and we have requested a Type A meeting with FDA to discuss next steps for resubmitting our BLA,” Scholar Rock said in a statement. “We plan to share more information during our third quarter 2025 business update call in November.”  

In December 2024, Novo Holdings completed its $16.5 billion acquisition of Catalent and the related $11 billion acquisition by Novo Nordisk of three manufacturing sites from Novo Holdings. Located in Bloomington, Anagni, Italy, and Brussels, Belgium, the three sites were acquired to boost production of Novo Nordisk’s wildly popular blockbuster GLP-1s.