Disetronic Swiss Facility QS Problems Draw Warning Letter, Import Alert
This article was originally published in The Gray Sheet
Executive Summary
Roche Diagnostics is working with FDA to resolve quality systems issues uncovered at the Burgdorf, Switzerland facility of recently acquired insulin pump maker Disetronic Medical Systems
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Roche shows its Spirit
Firm launches its Accu-Chek Spirit diabetes self-management system in the U.S. Oct. 10 following a lift of FDA's import ban on Roche insulin pumps. The hold - in effect since pump maker Disetronic Medical Systems, purchased by Roche in May 2003, received an FDA warning letter in June 2003 - was lifted Oct. 9 following inspection of the Swiss manufacturing site last year (1"The Gray Sheet" July 21, 2003, p. 7). Accu-Chek Spirit, cleared by FDA in 2005, is compact and can be programmed discreetly, the company says. The insulin pump already is sold in 30 countries. Roche is one of a number of firms striving to reach the U.S. market with continuous glucose monitoring technology, where it would compete with Medtronic's Paradigm and Guardian offerings and DexCom's STS system...
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