A plant operated by Roche Diagnostics for the manufacture of insulin pumps has serious regulatory compliance problems, according to a letter posted on the US Food and Drug Administration's website.
The plant, based in Burgdorf, Switzerland, is operated by Disetronic Medical Systems, which was acquired by Roche in May. A Reuters report noted that Disetronic had responded to prior FDA requests to bring the plant into compliance on three separate occasions. However, the FDA's letter indicates it has not been successful.
The agency said that the deficiencies "may be symptomatic of serious underlying problems in the Disetronic manufacturing and quality assurance systems" and warned that the company is at risk of its products being detained on entry into the US unless the problems are corrected.
Roche paid €1.1 billion for Disetronic, which is the second-largest manufacturer of insulin pumps after Medtronic of the US. The company said it was working as quickly as possible to ensure that the Burgdorf facility was brought into line.
The FDA will need to undertake an additional inspection of the site to verify that it meets cGMP standards.