FDA Flags Manufacturing Deficiencies at Novo Nordisk Plant
Novo Nordisk’s manufacturing site in Bloomington, Indiana, has once again drawn scrutiny from the U.S. Food and Drug Administration (FDA). Following an inspection in late June and July, the agency issued a Form 483 with six observations highlighting a series of manufacturing deficiencies.
Key Issues Uncovered
The FDA cited issues including insufficient investigations into contamination, equipment failures, and lapses in environmental monitoring. According to the Form 483, the company did not adequately follow through on findings of contaminants, such as a piece of cat hair and repeated cases of human hair discovered in vial stoppers. The regulator also noted that Novo Nordisk failed to fully assess the impact of a bacterial incursion and did not identify root causes or corrective actions when pests were detected in controlled areas.
Additional concerns included the company’s handling of critical equipment failures, procedures to prevent microbiological contamination, and monitoring of aseptic processing areas. The FDA also questioned whether Novo’s quality control practices were sufficient to maintain drug consistency.
A final observation focused on the company’s reliance on supplier analyses for high-risk components, specifically polysorbate 20 and polysorbate 80, without conducting its own testing. These ingredients are used in the production of Regeneron’s Eylea and Libtayo, among other medicines.
Novo Nordisk’s Response
In response, a Novo Nordisk spokesperson confirmed receipt of the Form 483. “We take all observations seriously and have initiated a thorough review of our processes and procedures,” the company said. The spokesperson added that a comprehensive response will be implemented to address the findings “promptly and holistically.” Novo further stated that it welcomes future FDA inspections as it works to ensure continuous improvement and patient safety.
History of Regulatory Challenges
This development marks another instance in which the Bloomington facility has faced regulatory attention. The plant has previously been tied to delays and setbacks in approvals for Regeneron products, including the postponement of a regulatory decision for Eylea HD and the rejection of a separate cancer therapy.
Novo Nordisk acquired the Bloomington plant, along with sites in Anagni, Italy, and Brussels, Belgium, through Novo Holdings’ purchase of Catalent in December. Novo Holdings serves as the parent company of Novo Nordisk under the Novo Nordisk Foundation.
The Indiana site has a history of regulatory challenges. In the fall of 2023, the FDA cited similar manufacturing violations during an inspection. Earlier in the same year, deficiencies identified by the agency led to the rejection of Regeneron’s high-dose Eylea. Production issues at the facility also contributed to the delayed release of Moderna’s COVID-19 vaccine boosters in 2022.
Wider Industry Impact
In early August, Regeneron pointed to problems at the Bloomington plant as a factor in multiple regulatory setbacks for its therapies. Chief executive officer Len Schleifer voiced confidence in Novo’s ability to address the challenges but noted that the plant manufactures products for many leading biopharmaceutical companies, cautioning that other drugs could also face regulatory difficulties as a result.
The ongoing oversight highlights the plant’s central role in drug production and the importance of resolving compliance concerns identified by the FDA.
