# FDA 483 - Echopixel, Inc. - December 02, 2022

Source: https://www.globalkeysolutions.net/records/483/echopixel-inc/3c9ac62f-6f4b-4637-a6b6-45427b6b266e

> FDA 483 for Echopixel, Inc. on December 02, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Echopixel, Inc.
- Inspection Date: 2022-12-02
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: Echopixel, Inc. in Santa Clara, CA, was inspected by the FDA from November 29 to December 2, 2022. The inspection resulted in one observation regarding the firm's quality system. Specifically, the firm lacked adequately defined procedures for design validation, particularly concerning code reviews for software modifications.

## Related Documents

- [483 - 2025-01-15](https://www.globalkeysolutions.net/records/483/echopixel-inc/664dfaf9-f2d9-4afa-8418-bee58c5ba9b7)

## Related Officers

- [Kenya Destin](https://www.globalkeysolutions.net/people/kenya-destin/1a367d64-8171-4dfd-bb1f-78d8b96a99f5)

Company: https://www.globalkeysolutions.net/companies/echopixel-inc/fa2eed1b-8dbd-4aeb-8dae-527b89587c30

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