483
Snap Diagnostics, LLC.Snap Diagnostics, LLC. – FDA 483, Feb 13, 2026
Record Details
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.
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- Chicago District Office
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ID · 109d88ea-9bb5-4632-b964-785a7d170cb5
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