# FDA WARNING_LETTER - Unetixs Vascular, Inc. - October 29, 2019

Source: https://www.keypedia.com/records/warning_letter/unetixs-vascular-inc/a65f7ed2-4a62-4333-a2a8-6226d0a719f8

> FDA WARNING_LETTER for Unetixs Vascular, Inc. on October 29, 2019. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Unetixs Vascular, Inc.
- Inspection Date: 2019-10-29
- Product Type: Devices
- Office Name: Office of Medical Device and Radiological Health Operations (Division 1)
- Summary: The FDA issued a Warning Letter to Unetixs Vascular Inc. on February 4, 2020, following an inspection from September 17 to October 29, 2019. The inspection revealed that Unetixs, a manufacturer of vascular diagnostic ultrasound systems like the MultiLab® Series, had adulterated devices under 21 U.S.C. § 351(h) due to non-conformity with current good manufacturing practice requirements of the Quality System regulation (21 CFR Part 820).

Significant violations include:
1.  **Failure to control device design (21 CFR § 820.30(a))**: Specifically, the MultiLab® Series ROODRA, distributed since September 28, 2018, lacked established design and development plans, design inputs, design outputs, design reviews, and design validation. A Design History File (DHF) compliant with FDA requirements was not established prior to distribution.
2.  **Failure to control production processes (21 CFR § 820.70(a))**: No approved procedures existed for ROODRA manufacturing, including testing for electrical leakage, acoustic output, EMC, and electrical safety.
3.  **Failure to establish acceptance activities procedures (21 CFR § 820.80(a))**: Four lots of Revo motherboards, a critical component

## Related Documents

- [483 - 2018-06-11](https://www.keypedia.com/records/483/unetixs-vascular-inc/97d4301b-79fe-4c2d-8da4-30eb07529925)
- [483 - 2019-10-29](https://www.keypedia.com/records/483/unetixs-vascular-inc/91c017b6-d81d-4303-9612-d2edbc066454)
- [483 - 2021-07-30](https://www.keypedia.com/records/483/unetixs-vascular-inc/4f248eff-dec8-4a48-9d48-d2b698f06695)
- [483 - 2022-09-16](https://www.keypedia.com/records/483/unetixs-vascular-inc/485f00fd-0f64-41db-ae3a-c52fc8f3e20d)
- [WARNING_LETTER - 2025-12-04](https://www.keypedia.com/records/warning_letter/unetixs-vascular-inc/99504038-5005-45ca-b944-b6827dedf8a1)

## Related Officers

- [Vinod Ramani](https://www.keypedia.com/people/vinod-ramani/71de48b9-c14b-4ec8-b355-e29fac455acf)
- [Director of Compliance Branch](https://www.keypedia.com/people/gina-brackett/fa52f03a-8a7e-485e-8773-a1da3fa628d7)

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

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-operations-division-1/c2b03748-4c7c-4f76-b2ea-bc8f47e6e7f2