# FDA 483 - Unetixs Vascular, Inc. - July 30, 2021

Source: https://www.keypedia.com/records/483/unetixs-vascular-inc/4f248eff-dec8-4a48-9d48-d2b698f06695

> FDA 483 for Unetixs Vascular, Inc. on July 30, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Unetixs Vascular, Inc.
- Inspection Date: 2021-07-30
- Product Type: device
- Office Name: Division of Northeast Imports 
- Summary: Unetixs Vascular, Inc. in Warwick, RI, received a Form FDA-483 with six observations, including two repeat observations, following an inspection from July 7-30, 2021. The inspection revealed significant deficiencies across multiple quality system areas, indicating a failure to adequately establish and follow procedures. Key issues include inadequate corrective and preventive actions, design change control, complaint handling, nonconforming product control, supplier management, and medical device reporting.

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## Related Officers

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

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

Office: https://www.keypedia.com/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94