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# Repeat QS Violations in US Vascular Inspection
- URL: https://www.fdaweb.com/repeat-qs-violations-in-us-vascular-inspection/
- Published: 2018-11-13T12:00:00.000Z
- Updated: 2026-09-15T00:44:26.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5142806

A 3/26-3/30 FDA inspection at US Vascular, LLC, Beaverton, OR, found Quality System and Medical Device Reporting violations in the firm’s manufacturing of Class 2 VascuLab devices used in vascular pathology. A just-released 6/7 [Warning Letter](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm625034.htm?ref=fdaweb.com) says violations were: 

- failing to establish procedures for design control;
- failing to establish procedures for receiving, reviewing, and evaluating complaints by a formally designated unit;
- failing to establish procedures for corrective and preventive action;
- failing to establish procedures for design change;
- failing to establish procedures to ensure that all purchased or otherwise received product and services conform to specified requirements;
- failing to establish procedures for acceptance activities;
- failing to establish procedures to control product that does not conform to specified requirements;
- failing to maintain a device master record;
- failing to establish document control procedures;
- failing to establish procedures for device history records;
- failing to establish procedures for quality audits; and
- failing to implement written Medical Device Reporting procedures.

The letter says many of the inspection observations are repeated from 2016 and 2017 inspections. “Historically, you have promised corrections and to date, adequate corrections have not been observed even after you purchased procedures which were never fully implemented in the past,” the letter says.

US Vascular was told to take prompt action to correct the violations and respond with a list of specific steps taken to correct the violations and prevent their recurrence, with documentation of each step, and a timetable for completion.