# FDA 483 - Examinetics Inc - October 05, 2023

Source: https://www.keypedia.com/records/483/examinetics-inc/e04d260e-2bd1-4770-8371-c158917a9cb9

> FDA 483 for Examinetics Inc on October 05, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Examinetics Inc
- Inspection Date: 2023-10-05
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: 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.

## Related Officers

- [Eric C. Fox](https://www.keypedia.com/people/eric-c-fox/218af117-1551-476f-80ba-172e2cd6baee)

Company: https://www.keypedia.com/companies/examinetics-inc/8ccaa155-78e5-45ab-bbd5-3fcefa0b5771

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-ii/8851d151-0390-4d17-be66-fd86d12aa6b8