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

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.