Inside the Catalent FDA citation said to trigger Novo Nordisk's Wegovy supply hiccup

The story of how an FDA write-up at one of Catalent's European plants contributed to supply difficulties for Novo Nordisk's obesity med Wegovy has been slow to develop, but more details are now coming to light.

Investigators dinged Catalent’s syringe filling facility in Brussels, Belgium for failing to thoroughly investigate batch failures or discrepancies, according to an FDA citation published Tuesday by BioProcess International. The CDMO also struggled with issues related to high-efficiency particulate absorbing (HEPA) filter failures, problems establishing written procedures for production and process control, plus subpar equipment maintenance, among other glitches highlighted in the seven-observation Form 483.