# FDA 483 - Zynex Medical, Inc - June 15, 2022

Source: https://www.keypedia.com/records/483/zynex-medical-inc/ef1ae8d5-9b00-4b31-be61-cf8b61dd7d6a

> FDA 483 for Zynex Medical, Inc on June 15, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Zynex Medical, Inc
- Inspection Date: 2022-06-15
- Product Type: device
- Office Name: Denver District Office
- Summary: An FDA inspection of Zynex Medical, Inc. in Englewood, CO, revealed significant deficiencies in the firm's quality system. Observations included inadequate procedures for corrective and preventive actions, rework of nonconforming products, acceptance of incoming products, and internal quality audits. These issues suggest a need for comprehensive improvements in the firm's quality management processes.

## Related Documents

- [EIR - 2022-06-15](https://www.keypedia.com/records/eir/zynex-medical-inc/d54371ec-d9cc-4539-8528-619a0c54126d)

## Related Officers

- [investigator](https://www.keypedia.com/people/matthew-m-vernon/f77e8c18-8614-49e3-9b19-3327b7fe7648)

Company: https://www.keypedia.com/companies/zynex-medical-inc/584368a0-d540-4459-a435-34ea5562fcaf

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