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

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.