STAT+: Major U.S. drug manufacturing plant did not properly investigate cat hair, pests, and other problems, FDA finds

Cat hair, pests, bacteria, and equipment failures.

These were among the concerns of a recent regulatory inspection of a key, but historically troubled, manufacturing plant that Novo Nordisk bought last year as part of its parent company’s acquisition of Catalent, one of the largest contract manufacturers serving the pharmaceutical industry. A copy of a Food and Drug Administration inspection report was obtained by STAT.

The extensive problems seen by the FDA, some of which were noted in previous inspections over the past three years, are raising concerns for drugmakers such as Regeneron Pharmaceuticals and Scholar Rock. And Wall Street analysts are keeping close watch for signs that the issues may also affect other drug companies that rely on the facility.

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