BIOXIN MEDICAL CO., LTD – FDA 483, Apr 4, 2019

An FDA inspection of UW ICU Medical Limited in Weihai, China, identified several deficiencies in their quality system. Observations included inadequate documentation of rework activities and validated processes, as well as poorly established procedures for environmental controls and internal quality audits. These findings indicate a need for the firm to enhance its compliance with medical device manufacturing regulations.