FDA Reinspection of Troubled Novo Nordisk Facility

FDA has documented GMP issues at a long-troubled Bloomington, IN, fill-finish facility — formerly owned by Catalent and acquired by Novo Nordisk in late 2024 — according to a Form 483 issued following an April reinspection.

The Catalent facility was hit last year with a Warning Letter that cited significant GMP violations after investigators found repeated failures to properly investigate contamination events and aseptic processing risks. The facility has a history of compliance troubles. Most recently, FDA assigned an “Official Action Indicated” classification to a July 2025 inspection (see story) that revealed significant GMP deficiencies. The serious compliance designation has delayed the approval and production timelines for drug products, including those from partner companies Regeneron and Scholar Rock, which are made at the plant.

A central concern outlined in the letter involved widespread contamination of finished drug products with extrinsic “mammalian hair,” an issue FDA said the company failed to adequately investigate, trend, or remediate over an extended period.

The April inspection resulted in eight observations at the site, grouped by Jefferies analysts into three recurring themes: persistent contamination and control failures, inadequate contamination control and inspection validation, and systemic deficiencies in quality systems and investigation practices. The Jefferies findings were detailed in a 5/27 note to investors.

The contamination problems at the Bloomington plant are not new — and that's precisely the concern. The FDA cited recurring particulate contamination, including the presence of mammalian hair, alongside repeated aseptic processing failures and water leakage events that persisted despite prior corrective actions and root-cause investigations, according to the Jefferies analysis.

Novo Nordisk, in a statement to Pharma Manufacturing, said it "welcomed" the inspection as "an expected and important step" in its ongoing compliance work, expressing confidence that the reinspection "reflects the meaningful progress we have made." The company pushed back on the mammalian hair finding specifically, arguing that the contamination was caught through "normal manufacturing controls" and that all affected batches were identified and will be rejected. Novo framed it as a meaningful distinction — contamination found and caught during manufacturing versus contamination found in released product.

Regulators may or may not see it that way. FDA has 90 days from the April 24 close of the inspection to formally classify the Bloomington site — meaning a decision is expected by late July 2026. According to Jefferies, the agency may use the full review window before issuing a ruling. If the agency issues another OAI classification, it would likely trigger additional delays on the Regeneron and Scholar Rock applications and raise serious questions about whether Novo Nordisk's remediation plan is working. A voluntary action indicated (VAI) or no action indicated (NAI) classification, by contrast, would clear a significant hurdle for the companies.

Novo Nordisk has said it is confident in its corrective and preventive actions, and all eyes will be on how FDA classifies the inspection next month.