Novo Nordisk's Wegovy Supply Delays: FDA Uncovers Catalent Factory Lapses Violating Safety Regulations

The production facility that fills the self-injection pens for the rapidly-growing weight-loss medication Wegovy from Novo Nordisk A/S NVO has been found to have persistently violated U.S. sterile-safety regulations in recent years.

Employees at the Catalent Inc CTLT factory, which handles Wegovy's pen-filling process, did not carry out required quality checks consistently, Reuters reported citing regulatory documents. 

These violations were discovered by the FDA inspectors who visited the Brussels-based plant in October 2021 and August 2022 to assess its manufacturing regulatory compliance. 

Despite the lapses, no evidence indicates Catalent's compliance issues led to any harm to Wegovy users.

According to inspection reports, due to the violations, Catalent halted its operations twice between the two inspections. 

However, the FDA allowed the facility to continue operating while addressing the issues, as the agency did not deem them public safety risks.

Throughout 2022, shipments of Wegovy were delayed as Catalent tackled problems identified by the FDA inspections. 

One of the most significant findings from the FDA's October 2021 inspection was the repeated failure of the plant's air-filtration systems, crucial for maintaining sterility, between 2017 and 2021. 

The inspection also found new air quality issues in sterile zones and failures in performing required safety checks.

Novo has faced criticism from investors over its choice of Catalent as a manufacturing partner, given the substantial demand for Wegovy.

The specific issues at the Catalent factory must be addressed to prevent potential enforcement action, such as drug seizures. The resolution of these issues will be crucial for Novo and Catalent as they aim to meet the growing demand for Wegovy in the U.S.

Price Action: NVO stock is down 0.45% at $157.56, CTLT shares are down 0.53% at $48.64 on the last check Thursday.

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