Novo Nordisk has received a warning letter from the US FDA following quality lapses at its Bloomington, Indiana manufacturing facility. The site was acquired from Catalent last year and has faced ongoing regulatory scrutiny.
The warning letter, dated November 20 and published on December 11, followed an FDA inspection conducted between June 23 and July 14.
That inspection resulted in a Form 483 issued in August, highlighting multiple compliance concerns. In October, the FDA escalated the matter by assigning the facility an Official Action Indicated (OAI) status, its most serious regulatory classification.
According to the FDA, Novo Nordisk failed to adequately investigate more than 20 deviations linked to potential drug contamination.
The contamination involved mammalian hair found near the stopper region of vials. The Form 483 specifically identified both cat hair and human hair.
The FDA expressed concern that Novo released product batches despite unresolved contamination risks. In several cases, customers rejected batches after they had already been distributed.
“While we recognize efforts to work with suppliers, releasing affected batches remains unacceptable,” the FDA stated.
The issue became public after Scholar Rock, a Novo Nordisk manufacturing client, disclosed the warning letter in a securities filing. The situation underscores the regulatory risks tied to post-acquisition manufacturing transitions.
For Novo Nordisk, resolving quality systems gaps at the Bloomington site is now a regulatory priority, not an option.