West Wake News

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

This is a 100% increase over the number of companies cited in the previous quarter.

The citations in the county include:

• Requirements that must be met by suppliers have not been adequately established.
• Procedures for acceptance activities have not been adequately established.
• Procedures have not been adequately established to control product that does not conform to specified requirements.

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
GlaxoSmithKline, LLC	Drugs	04/19/2024	Complaint Handling Procedure
Suntech Medical, Inc.	Devices	05/22/2024	Evaluation of suppliers, contractors, etc., requirements
Suntech Medical, Inc.	Devices	05/22/2024	Lack of or inadequate procedures - Acceptance activities
Suntech Medical, Inc.	Devices	05/22/2024	Nonconforming product, Lack of or inadequate procedures
Suntech Medical, Inc.	Devices	05/22/2024	Lack of or inadequate procedures
Suntech Medical, Inc.	Devices	05/22/2024	Lack of or inadequate complaint procedures