Troubled Novo Nordisk Facility Gets OAI Status

FDA has given an “Official Action Indicated (OAI)” classification to a recent inspection of a Novo Nordisk manufacturing facility in Bloomington, IN. The July inspection revealed significant GMP deficiencies. The serious compliance designation could delay the approval and production timelines for drug products, including those from partner companies, including Regeneron and Scholar Rock, that are made at the plant.

The facility, which Novo Nordisk acquired from Catalent in December 2024, has a history of FDA scrutiny that predates the acquisition. The latest inspection, according to a Form FDA-483, identified a range of serious problems:

• Contamination Issues: The facility was cited for unresolved concerns, including the presence of cat hair, human hair in vial stoppers, bacterial contamination, and pests in classified areas. Investigators noted that root causes weren’t established, nor were the broader impacts on drug lots assessed.
• Equipment Failures: The plant reportedly had recurrent equipment failures, including leaks, that were not properly investigated or remedied in a timely manner.
• Testing and Controls Lapses: FDA also flagged inadequate environmental monitoring in aseptic areas and the facility's reliance on supplier testing for high-risk components (such as polysorbate 20 and 80) without conducting independent verification

In response, Novo Nordisk says it is working with FDA and its customers, confirming that addressing manufacturing standards is a “top priority.”

Earlier this year, FDA released a four-page Form FDA-483 that was issued after the agency inspected the manufacturing facility 5/4-12. According to the inspection form, the facility was cited over written production and process control procedures not being followed or established. Additionally, the agency said the facility’s equipment revalidation was inadequate, and equipment and facilities were not adequately maintained or cleaned.

This is not the first time the Bloomington plant has had issues. In late 2023, FDA delayed Regeneron’s high-dose Eylea approval by two months due to cleaning and procedural deficiencies at the same facility, then still under Catalent’s ownership.

Recently, FDA has extended until the fourth quarter (see earlier story) the review of two Regeneron Pharmaceuticals regulatory submissions for Eylea HD (aflibercept) injection 8 mg because information submitted to address a recent inspection at the facility was deemed a major amendment. One submission was a chemistry, manufacturing and controls prior-approval supplement for the Eylea HD prefilled syringe, and the other was a supplemental BLA seeking approval for both the treatment of macular edema following retinal vein occlusion and the broadening of the dosing schedule to include every four-week (monthly) dosing across approved indications, according to the company.

Additionally, the OAI status could trigger further FDA enforcement actions, such as Warning Letters and injunctions. A facility with this classification typically requires an on-site follow-up inspection to verify that all corrective actions have been fully implemented before the status can be changed.