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

Source: https://www.keypedia.com/records/483/snap-diagnostics-llc/e67c0b26-c242-440f-b3dc-69535b506842

> 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: FDA District Office — Chicago, Illinois
- Summary: Snap Diagnostics, LLC. in Vernon Hills, IL, was cited for significant deficiencies in its quality system related to its SAM Model 9-10000 Sleep Apnea Recorder. The inspection revealed inadequate corrective actions for a high-failure-rate effort sensor, poorly documented risk management processes, and failures in controlling nonconforming products. These issues led to the continued distribution of potentially problematic devices and an underestimation of patient risk.

## Related Documents

- [483 - 2026-02-13](https://www.keypedia.com/records/483/snap-diagnostics-llc/109d88ea-9bb5-4632-b964-785a7d170cb5)

## 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/fda-district-office-chicago-illinois/62c2811c-10c5-4d74-99d0-eb5047ef3b65