Disetronic Pump Starts Stopped in US
Senior Disetronic representatives reported that the FDA has issued an embargo on importation of new Disetronic insulin pumps into the United States as a result of a problem with documentation of the manufacturing processes of the company. The embargo means that new patients cannot be started on Disetronic insulin pumps. The FDA action does not affect the ability of Disetronic to provide support to existing pump users. The embargo is expected to remain in place for several months.
- FDA Letter to Roche, dated July 11, 2003, outlining the issues responsible for the embargo (PDF format)
- Roche gets FDA warning on insulin pump plant (July 15, 2003)
June 14, 2003
Updated July 20, 2003
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