FDA 483 - ReNovo, Inc. - June 18, 2018

ReNovo, Inc., a reprocessor in Bend, OR, was cited for deficiencies related to its supplier and contractor management. The inspection revealed inadequate documentation for the evaluation and approval of contractors, as well as a lack of formal agreements requiring suppliers to notify the firm of product or service changes. These issues indicate weaknesses in the firm's quality system regarding external party controls.