FDA Raises Concerns Over Serious Contamination Issues at Novo Nordisk Indiana Facility, Including Cat Hair, Bacteria, and Foreign Objects

FDA Quality Control Failures: The FDA has reported multiple quality control issues at Novo Nordisk's Bloomington, Indiana facility, including contamination with foreign particles and inadequate investigations into these problems.

Acquisition of Fill-Finish Sites: In 2024, Novo Nordisk acquired three fill-finish sites for $11 billion from Novo Holdings, which are crucial for the sterile filling of drugs.

Contamination Issues: Internal records revealed persistent contamination issues, including hair and unidentified particles, with at least 20 deviations reported since July 2024, alongside bacterial contaminations and pest infestations.

Regulatory Concerns: Regulatory scrutiny extends to other companies, such as Regeneron Pharmaceuticals, which faces potential delays in FDA approvals due to observations linked to Catalent’s Indiana facility.