FDA 483 - ROE DENTAL LAB INC - October 11, 2022

ROE DENTAL LAB INC, a medical device manufacturer in Independence, OH, was inspected by the FDA from September 26 to October 11, 2022. The inspection revealed significant deficiencies across its quality system, including unvalidated manufacturing processes, inadequate complaint handling, and a complete lack of a functional CAPA system. The firm also failed to establish proper controls for suppliers, non-conforming products, equipment calibration, internal audits, management reviews, and process controls.