# FDA 483 - NEXALIN TECHNOLOGY INC. - February 20, 2020

Source: https://www.keypedia.com/records/483/nexalin-technology-inc/002bfd95-6ad3-4a2a-ba11-26867aba45d9

> FDA 483 for NEXALIN TECHNOLOGY INC. on February 20, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: NEXALIN TECHNOLOGY INC.
- Inspection Date: 2020-02-20
- Product Type: device
- Office Name: Dallas District Office
- Summary: NEXALIN TECHNOLOGY INC. in Houston, TX, a specification developer for a Class 3 transcranial electrotherapy stimulator (TESA), was inspected and found to have significant quality system deficiencies. The firm failed to maintain a device master record, establish adequate design control procedures, and properly document or implement corrective and preventive actions. Additionally, procedures for handling and evaluating customer complaints were not established, indicating a broad lack of adherence to quality system requirements.

## Related Documents

- [483 - 2023-03-10](https://www.keypedia.com/records/483/nexalin-technology-inc/be1e5c98-5c9c-483b-b3db-c992517bd8cf)

## Related Officers

- [Jocelyn C. Turner](https://www.keypedia.com/people/jocelyn-c-turner/7e39f6e0-9750-4460-8a4e-27ee9306b77e)

Company: https://www.keypedia.com/companies/nexalin-technology-inc/3cda8b7b-b766-4b8a-aa59-6f8cec791005

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9