483
Truer Medical IncFDA 483 - Truer Medical Inc - February 13, 2026
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Record Details
Truer Medical Inc. in Orange, CA, was inspected by the FDA from February 10-13, 2026. The inspection revealed a significant deficiency related to the firm's failure to maintain design and development files for several commercially distributed Class II medical devices, including temperature probes and esophageal stethoscopes. This indicates a lack of adherence to design control procedures for critical medical products.
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