West PDX Today

There was one company in a city associated with Washington County that received FDA citations as a result of one inspection conducted in the county in March, according to reports from the U.S. Food and Drug Administration (FDA).

This is an increase over the number of companies cited in the previous month.

The citations in the county include:

• Procedures for design change have not been established.
• Procedures for corrective and preventive action have not been adequately established.
• A device master record has not been adequately maintained.

The company cited should take a voluntary action to correct its managing operations.

The FDA routinely inspects facilities across the nation to determine if the workplace and their products are compliant with FDA-regulated laws and regulations implemented to improve overall public health. Inspection results are then disclosed publicly.

The FDA is a government agency that is primarily responsible for monitoring the production and distribution of human and animal drugs, biological products, medical supplies and tobacco products for safety quality, according to its website.

Company Name	Area of Business	Inspection Date	Issue Cited
US Vascular, LLC	Devices	03/06/2024	Design changes - Lack of or Inadequate Procedures
US Vascular, LLC	Devices	03/06/2024	Lack of or inadequate procedures
US Vascular, LLC	Devices	03/06/2024	DMR - not or inadequately maintained