# FDA 483 - Echopixel, Inc. - January 15, 2025

Source: https://www.globalkeysolutions.net/records/483/echopixel-inc/664dfaf9-f2d9-4afa-8418-bee58c5ba9b7

> FDA 483 for Echopixel, Inc. on January 15, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Echopixel, Inc.
- Inspection Date: 2025-01-15
- Product Type: device
- Office Name: San Francisco District Office
- Summary: An FDA inspection of Echopixel, Inc. in San Jose, CA, revealed significant deficiencies in its quality system. The firm failed to properly report a device correction/removal for malfunctioning software, inadequately maintained complaint files with conflicting dates, and did not perform quality audits at defined intervals. These observations highlight a lack of adherence to regulatory requirements for medical device manufacturers.

## Related Documents

- [483 - 2022-12-02](https://www.globalkeysolutions.net/records/483/echopixel-inc/3c9ac62f-6f4b-4637-a6b6-45427b6b266e)

## Related Officers

- [Brittany D. Mccracken](https://www.globalkeysolutions.net/people/brittany-d-mccracken/a869ecee-3b7b-4c1a-8c77-7efb1a3d902a)

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

Office: https://www.globalkeysolutions.net/offices/san-francisco-district-office/6f838e9c-aae1-4665-9c46-a51d43be02df