# FDA 483 - WAVi Co. - March 29, 2023

Source: https://www.globalkeysolutions.net/records/483/wavi-co/73494e8b-acaf-4949-bd56-55c8739421f0

> FDA 483 for WAVi Co. on March 29, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: WAVi Co.
- Inspection Date: 2023-03-29
- Product Type: device
- Office Name: Denver District Office
- Summary: WAVI Co., a medical device manufacturer in Denver, CO, was cited for significant deficiencies across its quality system during an FDA inspection. Observations included a lack of software validation for distributed EEG systems, inadequate CAPA procedures, and failures in establishing proper procedures for acceptance activities, complaint handling, equipment calibration, and quality audits. The inspection revealed systemic issues in documentation, process validation, and quality control, with some issues being repeat observations.

## Related Documents

- [483 - 2018-01-29](https://www.globalkeysolutions.net/records/483/wavi-co/7fb67649-78a8-4024-b830-7661610db669)
- [483 - 2018-12-21](https://www.globalkeysolutions.net/records/483/wavi-co/41439e25-471e-45e8-91fd-b269e52a9ae2)
- [483 - 2022-03-31](https://www.globalkeysolutions.net/records/483/wavi-co/322293e7-e77f-481b-923c-f9578a8dfb51)
- [WARNING_LETTER - 2023-03-29](https://www.globalkeysolutions.net/records/warning_letter/wavi-co/f1078981-a77d-4d0e-a2e2-6536c8105988)
- [483 - 2024-12-16](https://www.globalkeysolutions.net/records/483/wavi-co/a7b7e3af-1179-4c09-8d6b-68bd43ea16a6)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/christine-i-shaw/480cb61e-f173-432d-b84a-c8b492192302)

Company: https://www.globalkeysolutions.net/companies/wavi-co/882afa5a-acc0-467c-be14-85c19552e244

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