West PDX Today

There were two companies in cities associated with Washington County that received FDA citations as a result of two inspections conducted in the county over the first quarter of 2024, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 50% decrease from the number of companies cited in the previous quarter.

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.

Both companies cited should take voluntary actions to correct their 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
Global Importing Group, Inc.	Food and Cosmetics	01/08/2024	Develop FSVP
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