# FDA 483 - Vision Chips Inc - February 27, 2026

Source: https://www.keypedia.com/records/483/vision-chips-inc/9b263299-8142-4cdb-aadb-bdc8f88dfc34

> FDA 483 for Vision Chips Inc on February 27, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Vision Chips Inc
- Inspection Date: 2026-02-27
- Product Type: device
- Office Name: Los Angeles District Office
- Summary: Vision Chips, Inc. in Laguna Niguel, CA, a medical device manufacturer, was inspected by the FDA. The inspection revealed one significant observation concerning the firm's failure to implement Unique Device Identifier (UDI) requirements for its Class II medical image management and processing system, Observer 7. This indicates a non-compliance with labeling regulations for medical devices.

## Related Officers

- [Tyler J. Chia](https://www.keypedia.com/people/tyler-j-chia/0f17c8f0-f7bc-4e5d-bbfa-a8bc7aa5dd66)
- [Investigator](https://www.keypedia.com/people/alexandria-l-capuano/f76c710a-613f-42b2-8958-1292fa329112)

Company: https://www.keypedia.com/companies/vision-chips-inc/794fc532-39ae-4f36-a2da-d80e9f948c31

Office: https://www.keypedia.com/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b