MEDICAL DEVICES: 6829W

Warning Letter Bulletin | August 31, 1998 | Copyright

DeRoyal Cientifica de Central America, Barreal de Heredia, Costa Rica, May 1 (Office of Compliance). In a nine-page warning letter, FDA cited deviations from the QS regulation in the manufacture of esophageal stethoscopes, including failure to validate software and a bonding process; an unqualified ultraviolet curing conveyor system, oven and molding machine; inadequate procedures for incoming inspection and testing, as well as for handling nonconforming products; the release of finished devices without review and ...

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