Denmark-based Novo Nordisk ($NVO) said on Friday that it had received a subpoena from a U.S. Attorney who wants some info about its manufacturing operations at a plant in Kalundborg. But the company said it really has no idea why.
In an announcement, Novo said that the U.S. Attorney in Massachusetts asked for "documents regarding potential manufacturing issues within certain production units located in Kalundborg, Denmark." It said it was fully cooperating and that it takes "patient safety and product quality very seriously and is confident in the safety of its products."
In an email, spokesman Mike Rulis 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." GLP-1 is its Victoza product, a hot-selling Type 2 diabetes drug.
Novo Nordisk is not a company prone to recalls or manufacturing issues, but it is not completely immune. Last year, the company said that in June, it received a Complete Response Letter (CRL) from the FDA saying that issues at a plant found during an inspection were holding up completion of the review for its recombinant factor XIII compound for a rare bleeding disorder. The FDA approved it late last year. Rulis said Friday that factor XIII is not manufactured at the site in Kalundborg for which it received the subpoena.
In another stumble last year, the Danish drugmaker recalled 33 batches of insulin pens in the U.K. because of a manufacturing issue that led to a very small number of them having a very large disparity in their insulin fills.
In 2011, Novo said it would spend about $190 million to expand its facilities in Kalundborg.
- here's the release