# FDA 483 - Unetixs Vascular, Inc. - June 11, 2018

Source: https://www.globalkeysolutions.net/records/483/unetixs-vascular-inc/97d4301b-79fe-4c2d-8da4-30eb07529925

> FDA 483 for Unetixs Vascular, Inc. on June 11, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Unetixs Vascular, Inc.
- Inspection Date: 2018-06-11
- Product Type: device
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: OneLuxe Vascular Inc., a manufacturer in North Kingstown, RI, was cited for significant quality system deficiencies during an FDA inspection. The firm failed to establish adequate procedures for corrective and preventive actions, properly investigate device complaints, and ensure timely review of service records. All three observations were repeats, indicating persistent non-compliance with regulatory requirements.

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## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/maryam-tabatabaie/b792042d-e296-446d-90a9-d30c8f635506)

Company: https://www.globalkeysolutions.net/companies/unetixs-vascular-inc/806b7c9a-65a4-49da-9cd3-f6fa05fb9fdd

Office: https://www.globalkeysolutions.net/offices/fda-district-office-stoneham-massachusetts/1daceb4f-4057-46cf-af02-d4ccde44dcc7