# FDA 483 - Black Diamond Video - December 12, 2025

Source: https://www.keypedia.com/records/483/black-diamond-video/d8a3c388-2ba7-459a-a328-feb49dbe6ace

> FDA 483 for Black Diamond Video on December 12, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Black Diamond Video
- Inspection Date: 2025-12-12
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: 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.

## Related Documents

- [483 - 2025-12-12](https://www.keypedia.com/records/483/black-diamond-video/7abceda8-a1f8-484b-bd1c-711d7d63cbec)

## Related Officers

- [Jamie P. Webb](https://www.keypedia.com/people/jamie-p-webb/9e052469-54f7-4d56-b977-27babbdac09b)

Company: https://www.keypedia.com/companies/black-diamond-video/ce31973d-5999-40c9-9344-28409a7582d0

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b