483
b-Eye srlFDA 483 - b-Eye srl - October 11, 2018
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Record Details
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.
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ID · 59b31880-dcfb-411d-96e5-0de6e4dacde5