NE Valley Times

There was one company in a city associated with Maricopa County that received FDA citations as a result of one inspection conducted in the county over the fourth 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:

• The owner or operator of a repackager/relabeler did not submit the required device listing information for the establishment's device(s).
• Software validation activities and results for computers or automated data processing systems used as part of the quality system have not been adequately documented.
• Procedures have not been adequately established to control product that does not conform to specified requirements.

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
Globalmedia Group, LLC	Devices	10/25/2024	Devices not listed
Globalmedia Group, LLC	Devices	10/25/2024	Documentation of software validation
Globalmedia Group, LLC	Devices	10/25/2024	Nonconforming product, Lack of or inadequate procedures
Globalmedia Group, LLC	Devices	10/25/2024	Documentation
Globalmedia Group, LLC	Devices	10/25/2024	DMR device specifications
Globalmedia Group, LLC	Devices	10/25/2024	Lack of or inadequate complaint procedures