# FDA 483 - Snap Diagnostics, LLC. - February 13, 2026

Source: https://www.keypedia.com/records/483/snap-diagnostics-llc/109d88ea-9bb5-4632-b964-785a7d170cb5

> FDA 483 for Snap Diagnostics, LLC. on February 13, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Snap Diagnostics, LLC.
- Inspection Date: 2026-02-13
- Product Type: device
- Office Name: Chicago District Office
- Summary: An FDA inspection of Snap Diagnostics, LLC. in Vernon Hills, IL, revealed significant deficiencies in their quality system related to the manufacturing of the SAM Model 9-10000 Sleep Apnea Recorder. The firm failed to adequately implement corrective actions for a known high failure rate of effort sensors, properly manage product risks, and control nonconforming products. These issues could lead to delayed diagnoses for patients using the device.

## Related Documents

- [483 - 2026-02-13](https://www.keypedia.com/records/483/snap-diagnostics-llc/e67c0b26-c242-440f-b3dc-69535b506842)

## Related Officers

- [Shuana H. Xiong](https://www.keypedia.com/people/shuana-h-xiong/45ee2b1d-fbb8-452e-a218-8d79e8425fc8)

Company: https://www.keypedia.com/companies/snap-diagnostics-llc/067e97e5-b22b-4c32-b677-bb7b59af06db

Office: https://www.keypedia.com/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669