FDA 483 - Mego Afek AC Ltd. - February 06, 2020

Mego Afek AC Ltd. in Afek, Israel, a medical device manufacturer, was inspected by the FDA from February 3-6, 2020. The inspection revealed that procedures for finished device acceptance were not adequately established, leading to a medical device being released for distribution before all manufacturing and testing activities were completed. This indicates a failure to follow established quality procedures.