FDA 483 - ROE DENTAL LAB INC - October 23, 2023

ROE DENTAL LAB INC, a medical device manufacturer in Independence, OH, was inspected by the FDA from October 10-23, 2023. The inspection revealed significant deficiencies in their quality system, including inadequate validation of their dental abutment milling process, insufficient documentation of corrective and preventive actions, lack of established equipment calibration procedures, and failure to perform internal quality audits. These issues indicate a need for comprehensive improvements in their manufacturing and quality control processes.