Dallas City Wire

There was one company in a city associated with Collin County that received an FDA citation as a result of one inspection conducted in the county over the third quarter of 2024, according to reports from the U.S. Food and Drug Administration (FDA).

This is an 80% decrease from the number of companies cited in the previous quarter.

The only citation issued in the county was delivered as 'A process whose results cannot be fully verified by subsequent inspection and test has not been adequately validated according to established procedures'.

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
Van Duzen, Inc.	Devices	08/02/2024	Lack of or inadequate process validation