# FDA 483 - Expanse Medical Inc. - January 15, 2026

Source: https://www.keypedia.com/records/483/expanse-medical-inc/7223fcbf-c58e-4979-85d6-78be29785f68

> FDA 483 for Expanse Medical Inc. on January 15, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Expanse Medical Inc.
- Inspection Date: 2026-01-15
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: Expanse Medical Inc. in Pleasanton, CA, a medical device manufacturer, received a Form FDA 483 with three observations during an inspection from January 9-15, 2026. The inspection revealed significant deficiencies in design validation procedures, inadequate complaint handling processes, and a failure to submit required device information to the Global Unique Device Identification Database for their (b)(4) System. These issues indicate a lack of robust quality system controls for their Class II medical device.

## Related Documents

- [483 - 2026-01-15](https://www.keypedia.com/records/483/expanse-medical-inc/e84a18cc-fa6c-4d13-b1f0-a72302df93f7)

## Related Officers

- [Sara M. Onyango](https://www.keypedia.com/people/sara-m-onyango/643c6ad3-9747-4bc2-9e8e-72f97b11e659)

Company: https://www.keypedia.com/companies/expanse-medical-inc/e0f00950-f5ca-4e0e-92b7-714dc908fd40

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