FDA 483 - Custom Milling Center Inc - July 16, 2019

Custom Milling Center Inc, a contract manufacturer in Golden, CO, was cited for significant deficiencies in its quality system during an FDA inspection. The firm failed to adequately validate manufacturing processes for dental abutments and exhibited widespread issues across its quality management, including inadequate CAPA, complaint handling, nonconforming product control, and documentation practices. These observations indicate a systemic lack of established and followed procedures for critical medical device manufacturing operations.