FDA 483 - ApiFix, Ltd. - June 06, 2019

ApiFix, Ltd., a medical device manufacturer in Misgav, Israel, was inspected by the FDA and received a Form 483 with six observations. The inspection revealed significant deficiencies in their quality system, particularly concerning complaint handling, corrective and preventive actions, process validation, design change control, acceptance activities, and employee training. These issues indicate a lack of robust controls over critical aspects of device manufacturing and quality management.