# FDA 483 - Vela Operations USA, Inc. - June 01, 2022

Source: https://www.keypedia.com/records/483/vela-operations-usa-inc/0a9844bd-04cd-421d-9bdd-eabbe122bce4

> FDA 483 for Vela Operations USA, Inc. on June 01, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Vela Operations USA, Inc.
- Inspection Date: 2022-06-01
- Product Type: device
- Office Name: Denver District Office
- Summary: Vela Operations USA, Inc. in Salt Lake City, UT, a medical device manufacturer, was cited for multiple quality system deficiencies during an FDA inspection. Key issues include inadequate complaint handling, non-conforming material control, CAPA documentation, software validation, and a complete lack of internal quality audits, management reviews, and device history record procedures since 2018. The findings indicate systemic failures in maintaining a compliant quality management system.

## Related Officers

- [James R. Montero](https://www.keypedia.com/people/james-r-montero/ce2d19fd-25b7-423e-9132-5d6f582380d2)

Company: https://www.keypedia.com/companies/vela-operations-usa-inc/7ac8d550-3861-49fc-9648-d8ba6625eb7f

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