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US investigates Novo Nordisk manufacturing issues

Issues subpoena related to insulin plant in Kalundborg, Denmark
novo nordisk Kalundborg denmark
Novo Nordisk's site in Kalundborg, Denmark

Novo Nordisk was last week served with a subpoena by the US regarding manufacturing issues at its facilities in Denmark.

According to the company, the US Attorney for the District of Massachusetts has requested document related to production units in Kalundborg, which houses 15 factories producing Novo's insulins, its GLP-1 Victoza (liraglutide) and a haemophilia treatment.

Novo did not specify the particulars of the subpoena although the company said it was “cooperating fully with the US Attorney in this investigation”.

A statement said: “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.”

More than 2,800 Novo employees work at the site in Kalundborg on the west coast of Denmark. Units are involved in activities such as fermentation and purification, as well as filling, assembly and packaging facilities.

A company spokesperson told Reuters that production would continue on the site while the investigation takes place.

Novo's most recent manufacturing issue was an incident in 2013 when the company recalled several batches of its NovoMix prefilled insulin pen after an incorrect amount of insulin was found in a small number of the products.

Batches of the NovoMix30 FlexPen were recalled in Austria, Belgium, Czech Republic, Denmark, France, Germany, Iceland, Luxemburg, Netherlands, Norway and Slovakia, while batches of NovoMix Penfill were recalled in the UK and Ireland.

Article by
Thomas Meek

27th October 2014

From: Sales, Regulatory, Healthcare



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