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Article: MEDICAL DEVICES: 6829W
- Article from:
- Warning Letter Bulletin
- Article date:
- August 31, 1998
CopyrightCOPYRIGHT 1998 Washington Information Source, Inc. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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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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