Newly acquired Novo Nordisk plant struggles to meet quality standards, FDA finds

Last fall, FDA inspectors found multiple safety and quality issues at one of the manufacturing sites Novo Nordisk has agreed to purchase, according to a Feb. 6 Bloomberg report. 

The drugmaker on Feb. 5 announced it had agreed to buy three fill-finish manufacturing sites — which are in Italy, Belgium and Bloomington, Ind. — for $11 billion as part of its proposed acquisition of Catalent, a contract development and manufacturing organization based in Somerset, N.J. The deal is part of Novo's expansion efforts to bolster supply of its popular weight loss drug Wegovy. 

In October and November, FDA inspectors documented "multiple instances of workers failing to ensure the quality and purity of drugs produced," at the Bloomington facility, according to the Bloomberg report, which is based on an FDA inspection document it obtained through a Freedom of Information Act Request. Issues flagged by inspectors include a "pest" found somewhere on a manufacturing line handling syringes last June, as well as "brown residue" in the same area. 

In a statement to the news outlet, a Catalent spokesperson said the company takes "all regulatory inspections and any resulting observations very seriously," adding the company has been given time to voluntarily fix the issue after it developed a "comprehensive response and action plans" following the November inspection. 

The facility has made headlines several times in the past few years after FDA inspectors documented quality issues.

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