FDA 483 - Johns Dental Laboratories Inc. - July 14, 2023

Johns Dental Laboratories Inc. in Terre Haute, IN, was inspected and cited for multiple significant deficiencies in its quality system for medical devices. The inspection revealed a lack of established procedures for design controls, process controls, complaint handling, quality audits, corrective and preventive actions, and device history records. Additionally, the firm failed to appoint a management representative, indicating systemic issues in its quality management.