FDA Reveals Quality Issues at Danish Factory, Novo Nordisk Shares Plunge Nearly 1.1%

On Tuesday, October 29, Eastern time, Bloomberg published an interesting story. According to an inspection report released by the U.S. Food and Drug Administration (FDA) in March this year, the FDA conducted a detailed investigation of the Novo Nordisk plant in Kalundborg, Denmark. The findings revealed that the plant had a number of quality control problems and failed to provide sufficient evidence that the water it used for drug production met standards of cleanliness and safety. Especially when it comes to controlling certain microorganisms, these issues can negatively impact the quality and safety of the drug.

A spokesman for Novo Nordisk said the plant is primarily used to produce an insulin formulation that is used once a week. The US Food and Drug Administration (FDA) had already questioned this manufacturing process when it earlier refused to approve the product. The company is still in communication with the FDA, but a spokesperson said it may not be able to resolve the issue this year.

The market reacted strongly to the news, with Novo Nordisk's American Depositary receipts falling nearly 1.1% at one point in midday trading on Tuesday, hovering near nine-month lows.

In addition, Novo Nordisk manufactures semaglutide at another location in North Carolina, USA. Last September, the factory was also accused by the FDA of failing to properly investigate bacterial contamination. This has further heightened concerns about the quality and safety of Novo Nordisk's products.