FDA 483 - Black Diamond Video - December 12, 2025

Black Diamond Video Inc. in Richmond, CA, was inspected and cited for significant deficiencies in its quality system. The inspection revealed inadequate risk analysis, particularly concerning cybersecurity for its HexaVue Integration System, and a systemic failure to establish and follow corrective and preventive action procedures. Additionally, the firm lacked adequate procedures for receiving, reviewing, and consistently evaluating customer complaints.