Unetixs Vascular, Inc. – FDA Warning Letter, Oct 29, 2019

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