# FDA 483 - Unetixs Vascular, Inc. - September 16, 2022

Source: https://www.globalkeysolutions.net/records/483/unetixs-vascular-inc/485f00fd-0f64-41db-ae3a-c52fc8f3e20d

> FDA 483 for Unetixs Vascular, Inc. on September 16, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Unetixs Vascular, Inc.
- Inspection Date: 2022-09-16
- Product Type: device
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: An FDA inspection of Unetixs Vascular, Inc. in Warwick, RI, from September 12-16, 2022, revealed significant deficiencies in the firm's quality system. Observations included inadequate procedures for handling and investigating customer complaints, with hundreds of complaints remaining uninvestigated. Additionally, the firm failed to adequately control nonconforming products, specifically lacking proper investigation into the root cause of nonconformities.

## Related Documents

- [483 - 2018-06-11](https://www.globalkeysolutions.net/records/483/unetixs-vascular-inc/97d4301b-79fe-4c2d-8da4-30eb07529925)
- [483 - 2019-10-29](https://www.globalkeysolutions.net/records/483/unetixs-vascular-inc/91c017b6-d81d-4303-9612-d2edbc066454)
- [WARNING_LETTER - 2019-10-29](https://www.globalkeysolutions.net/records/warning_letter/unetixs-vascular-inc/a65f7ed2-4a62-4333-a2a8-6226d0a719f8)
- [483 - 2021-07-30](https://www.globalkeysolutions.net/records/483/unetixs-vascular-inc/4f248eff-dec8-4a48-9d48-d2b698f06695)

## 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