FDA Flags Alarming Contamination At Novo Nordisk Indiana Plant, Including Cat Hair, Bacteria, And Foreign Particles

The U.S. Food and Drug Administration (FDA) has identified repeated quality control failures, including foreign particle contamination, inadequate investigations, and insufficient corrective actions at the Novo Nordisk A/S (NYSE:NVO) operated facility in Bloomington, Indiana.

In 2024, Novo Nordisk acquired three fill-finish sites from Novo Holdings A/S for $11 billion. The acquisition was part of a larger deal where Novo Holdings acquired Catalent, Inc. (NYSE:CTLT).

The three sites, located in Anagni, Italy, Brussels, Belgium, and Bloomington, Indiana, specialize in the sterile filling of drugs.

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The company’s internal records revealed multiple deviations involving extrinsic contamination, such as cat hair and unidentified particles found during 100% manual visual inspections.

The problems were reported on Thursday by ...