# FDA 483 - ZYTO Technologies, Inc. - June 06, 2024

Source: https://www.keypedia.com/records/483/zyto-technologies-inc/defc7f01-ee52-4f4b-a88e-51e386f5c8d6

> FDA 483 for ZYTO Technologies, Inc. on June 06, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ZYTO Technologies, Inc.
- Inspection Date: 2024-06-06
- Product Type: device
- Office Name: Denver District Office
- Summary: ZYTO Technologies, Inc. in Pleasant Grove, UT, was inspected and cited for significant quality system deficiencies, many of which are repeat observations. The inspection revealed failures in design control, corrective and preventive action procedures, document control, and software validation for electronic records. These issues indicate a systemic lack of adherence to quality system requirements for their Class II Hand Cradle GSR Device.

## Related Documents

- [WARNING_LETTER - 2014-12-03](https://www.keypedia.com/records/warning_letter/zyto-technologies-inc/cfe124f7-b8ad-4448-b1da-48283f6dcb03)
- [483 - 2022-12-13](https://www.keypedia.com/records/483/zyto-technologies-inc/a052576b-4a7a-4078-af8c-13d0dfaabb6a)
- [WARNING_LETTER - 2022-12-13](https://www.keypedia.com/records/warning_letter/zyto-technologies-inc/9db93290-c955-4d1e-ad1b-3692a0080fb7)

## Related Officers

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

Company: https://www.keypedia.com/companies/zyto-technologies-inc/d31e352d-c434-4479-ac77-581fda10157a

Office: https://www.keypedia.com/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face