Disetronic Insulin Infusion Pumps
In response to a June 2003 warning letter sent by the U.S. Food and Drug Administration (FDA), Roche Diagnostics Corporation has decided to halt shipment of its Disetronic Insulin Infusion Pump. During a nine-day on-site investigation of Disetronic Medical Systems AG in Burgdorf, Switzerland on January 27-February 5, 2003, the FDA found serious problems involving the manufacture of external insulin infusion pumps. Roche acquired Disetronic in May 2003.
The inspection revealed that the devices are adulterated within the meaning of section 501(h) of the Federal, Food, Drug, and Cosmetic Act, in that the methods used in, or the facilities or controls used for their manufacture, packing, storage, or installation are not in conformance with the Current Good Manufacturing Practice requirements of the Quality System regulation, as specified in Title 21, Code of Federal Regulation , Part 820.
See your doctor if you have suffered injuries due to a Disetronic Insulin Infusion Pump. In addition, it may be important to contact an attorney who can help you protect your legal rights. Please keep in mind that there may be time limits within which you must commence suit.
Attorneys associated with InjuryBoard.com will evaluate your case free of charge. In addition, you will not pay any fees unless your attorney recovers money for you. Please click on the free Ask An Attorney button to take advantage of this valuable service.
-- Article Courtesy of InjuryBoard.com
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