Catalent hit with FDA 483 at Belgian fill and finish facility

A syringe filling facility in Brussels run by CDMO Catalent has received a US FDA Form 483 and has allegedly created supply issues for Novo Nordisk’s Wegovy.

The 265,000 square-foot site described as Catalent’s flagship European syringe filling facility produces over 175 million units annually for the contract development and manufacturing organization’s (CDMO’s) customers. But a recent inspection by the US Food and Drug Administration (FDA) discovered concerns at the site and resulted in a Form 483.

“We are treating the FDA’s 483 observations at the Brussels, Belgium, site very seriously and are working closely with them to resolve these, and with customers to minimize any potential disruptions this may cause to their supply chains,” a Catalent spokesperson told BioProcess Insider.

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Jefferies’ analyst David Windley named the Brussels site as the primary fill/finish supplier for Novo Nordisk’s weight loss drug Wegovy (semaglutide) in a note, and said the 483 was the reason behind recent supply chain issues.

On December 17, Novo Nordisk announced: “A contract manufacturer filling syringes for Wegovy pens for the US market has temporarily stopped deliveries and manufacturing following issues with Good Manufacturing Practices. As a consequence, Novo Nordisk does not expect to be able to meet demand in the US in the first half of 2022 and few new patients are expected to be able to initiate treatment.”

Windley added “the Brussels site has been no stranger to 483s. Over the past decade, that site has been issued 12 483s across the nine FDA inspection visits. We believe this is the first time a GMP-related 483 led to a halt in supply.”

He was, however, optimistic that the site’s reopening is “not contingent on FDA re-inspection, implying that the issue itself is not that severe and FDA is comfortable with Catalent’s remediation plan.”

Catalent could not confirm that Novo Nordisk is a customer at the Brussels site, nor that any specific products have been affected by the 483.

“Legally, and as a result of confidentiality agreements, Catalent cannot comment on individual customer contracts, their products, or particular manufacturing locations,” we were told.