Article: MEDICAL DEVICES.

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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 ...

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