# FDA 483 - Vevazz LLC - June 20, 2019

Source: https://www.keypedia.com/records/483/vevazz-llc/5409fa2f-3f5b-49c6-b3e9-5a657d43affc

> FDA 483 for Vevazz LLC on June 20, 2019. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Vevazz LLC
- Inspection Date: 2019-06-20
- Product Type: device
- Office Name: Denver District Office
- Summary: Vevazz LLC, a medical device manufacturer in Eaton, CO, was inspected by the FDA from June 3-20, 2019. The inspection revealed significant deficiencies across its quality management system, with 15 observations citing a lack of established or adequately implemented procedures for critical areas. These issues indicate a systemic failure to comply with medical device quality system regulations.

## Related Officers

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

Company: https://www.keypedia.com/companies/vevazz-llc/5ae5f79b-5a01-41a5-be72-7b6e1e24d035

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