FDA 483 - Black Diamond Video - December 12, 2025

Black Diamond Video Inc. in Richmond, CA, was inspected and received a Form 483 with three observations. The inspection revealed significant deficiencies in risk management, particularly concerning cybersecurity for their HexaVue medical integration systems, and a failure to adequately establish corrective and preventive action procedures. Additionally, the firm lacked proper procedures for receiving, reviewing, and evaluating customer complaints, leading to inconsistent handling and potential underreporting of issues.