483
Examinetics IncExaminetics Inc – FDA 483, Oct 5, 2023
Record Details
An FDA inspection of Examinetics Inc, a medical device manufacturer in Overland Park, KS, revealed significant quality system deficiencies. The firm failed to ensure design validation for its Class II Salux, Tablet-Controlled Audiometer, specifically regarding Bluetooth connectivity issues identified in pre-deployment testing and post-market complaints. Additionally, the company had not performed required internal quality audits of its quality system for the audiometer.
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ID · e04d260e-2bd1-4770-8371-c158917a9cb9
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