# FDA 483 - WAVi Co. - December 16, 2024

Source: https://www.globalkeysolutions.net/records/483/wavi-co/a7b7e3af-1179-4c09-8d6b-68bd43ea16a6

> FDA 483 for WAVi Co. on December 16, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: WAVi Co.
- Inspection Date: 2024-12-16
- Product Type: device
- Office Name: Denver District Office
- Summary: WAVI Co., a medical device manufacturer in Denver, CO, received a Form 483 with ten observations during a recent inspection, several of which are repeat findings. The inspection highlighted significant deficiencies across its quality system, including inadequate design history files, CAPA procedures, complaint handling, risk analysis, and document control. These issues collectively indicate a systemic failure to adhere to regulatory requirements and maintain adequate documentation practices.

## 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)
- [483 - 2023-03-29](https://www.globalkeysolutions.net/records/483/wavi-co/73494e8b-acaf-4949-bd56-55c8739421f0)
- [WARNING_LETTER - 2023-03-29](https://www.globalkeysolutions.net/records/warning_letter/wavi-co/f1078981-a77d-4d0e-a2e2-6536c8105988)

## 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