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.
