Novo Nordisk issued a statement to report that it has been served with a subpoena by the office of the US Attorney for the District of Massachusetts requesting documents regarding potential manufacturing issues within certain production units located in Kalundborg, Denmark.

“Novo Nordisk is cooperating fully with the US Attorney in this investigation,” said the company in an October 24, 2014 statement. “At this time, Novo Nordisk cannot determine or predict the outcome of this matter or assess the consequences thereof. In addition, the company cannot predict how long the investigation will take or when it will be able to provide additional information. Novo Nordisk takes patient safety and product quality very seriously and is confident in the safety of its products.”

According to the company’s annual filing, the site is one of its major production sites for active pharmaceutical ingredients (APIs), making APIs for drugs to treat diabetes and hemophilia. .

Source: Novo Nordisk