# FDA 483 - Ear Technology Corporation - May 24, 2022

Source: https://www.globalkeysolutions.net/records/483/ear-technology-corporation/a0c0cf67-d2b6-4020-b5a2-61f88bc26e46

> FDA 483 for Ear Technology Corporation on May 24, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ear Technology Corporation
- Inspection Date: 2022-05-24
- Product Type: device
- Office Name: New Orleans District Office
- Summary: An FDA inspection of Ear Technology Corporation in Johnson City, TN, a specification developer, revealed significant deficiencies in their quality management system. The firm lacked adequate procedures for complaint handling, supplier control, finished device acceptance, device history records, rework, and quality audits for their AllClean UV-C device. These issues indicate a systemic failure to establish and maintain essential quality system procedures.

## Related Officers

- [Benjamin E. Bowen](https://www.globalkeysolutions.net/people/benjamin-e-bowen/7fdc5755-0d5d-45c9-93a0-3cb928156c1d)

Company: https://www.globalkeysolutions.net/companies/ear-technology-corporation/a074108c-725f-4d16-aa74-11ace8d4bcbe

Office: https://www.globalkeysolutions.net/offices/new-orleans-district-office/95352142-b992-4e06-849d-d7483c0959ea