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Business

US subpoenas Novo Nordisk on Danish plant issues

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October 25th, 2014


This article is more than 10 years old.

Kalundborg plant site part of US investigation

Novo Nordisk said it had received a subpoena on Friday from the US Attorney requesting documents regarding potential manufacturing issues in its Kalundborg facility within certain production units, the company reports in a press release.

The company said the request is from the US Attorney office in the District of Massachusetts and is “cooperating fully” in the investigation, but “cannot determine or predict the outcome of this matter” and cannot “predict how long the investigation will take”.

In an email to FiercePharmaManfacturing, Mike Rulis, the spokesman for Novo, said “there’s not much I can add. We don’t know what has triggered the subpoena. Our site in Kalundborg, Denmark, comprises several plants which produce insulin, GLP-1 and factor VII.”

Few incidents in the past

Though Novo has a predominantly clean track record, it has had some issues in the recent past.

Last year the company recalled 33 batches of insulin pens in the UK due to an issue causing a small number of pens in the batch to have a large disparity in their insulin, reports FiercePharmaManufacturing.

Also last year, during an inspection, the company had issues at a plant that were holding up a US Food and Drug Administration review. The review was eventually approved late last year.

Rulis said the review was at a different site and not the Kalundborg site for which it received the subpoena.


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Moreover, 21 percent of those surveyed admitted to medicating their kids with paracetamol, such as Panodil, before sending them to school.

The FOLA parents’ organisation is shocked by the findings.

“I think it is absolutely crazy. It simply cannot be that a child goes to school sick and plays with lots of other children. Then we are faced with the fact that they will infect the whole institution,” said FOLA chair Signe Nielsen.

Pill pushers
At the Børnehuset daycare institution in Silkeborg a meeting was called where parents were implored not to bring their sick children to school.

At Børnehuset there are fears that parents prefer to pack their kids off with a pill without informing teachers.

“We occasionally have children who that they have had a pill for breakfast,” said headteacher Susanne Bødker. “You might think that it is a Panodil more than a vitamin pill, if it is a child who has just been sick, for example.”

Parents sick and tired
Parents, when confronted, often cite pressure at work as a reason for not being able to stay at home with their children.

Many declare that they simply cannot take another day off, as they are afraid of being fired.

Allan Randrup Thomsen, a professor of virology at KU, has heavily criticised the parents’ actions, describing the current situation as a “vicious circle”.

“It promotes the spread of viruses, and it adds momentum to a cycle where parents are pressured by high levels of sick-leave. If they then choose to send the children to daycare while they are still recovering, they keep the epidemic going in daycares, and this in turn puts a greater burden on the parents.”