Dutch blood company Sanquin is taking great risks with its efforts to move into the American market, the Volkskrant said in a major investigation at the weekend.

Sanquin is a privately held foundation which has a monopoly on blood supplies in the Netherlands and which hopes to process blood for the US market as part of its international expansion. However, it has run into trouble getting approval from the US Food and Drug Administration, the paper said.

FDA inspectors have recently been in the Netherlands to check out the company’s operations. Two previous visit resulted in reprimands for the Dutch company and a third official warning will have major implications because of the US policy of ‘three strikes and you are out’, the Volkskrant said.

Sanquin is responsible for collecting blood from donors in the Netherlands and supplying blood products to hospitals. The company hit the headlines earlier because of the large pay packets and bonuses it paid to some board members.

There is also pressure on the foundation to divide its activities into two, separating its public function from its commercial activities. Many donors have expressed concerns that blood they give free of charge is being used for commercial ends.

The company has made major investments in recent years in order to expand its medicine production capacity, resulting in the deal to process plasma for the US market.

However, it is clear the company needs to clarify its structure so that the public and commercial arms do not conflict with each other, the Volkskrant said in an editorial.