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Article: MEDICAL DEVICES.
- Article from:
- Warning Letter Bulletin
- Article date:
- September 11, 2000
CopyrightCOPYRIGHT 2000 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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Alfa Medical Equipment, Hempstead, NY, Aug. 22 (New York). FDA cited the maker of dry-heat sterilizers for failure to establish: a quality policy; procedures for design control; procedures for quality audits; and procedures for identifying personnel training needs. The letter also noted that Alfa did not document the rationale for a design change to a heating unit. The inspection of Alfa took place July 17-26. Design
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Allied Healthcare Products, St. Louis, MO, Aug. 3 (Kansas City). FDA cited the maker of circumcision clamps and emergency ventilators for failure to conduct audits according to schedule and to document audit plans ...