FDA 483 - b-Eye srl - October 11, 2018

An FDA inspection of b-Eye srl, a device manufacturer in Padova, Italy, revealed significant deficiencies in their quality system. Observations included inadequate procedures for design input, incomplete documentation for corrective and preventive actions, and a lack of established procedures for the review and disposition of nonconforming products. These issues indicate a need for improved quality management system controls.