Burlington Reporter

There were four companies in cities associated with Guilford County that received FDA citations as a result of four inspections conducted in the county over the fourth quarter of 2023, 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:

• The type and extent of control to be exercised over suppliers and contractors was not clearly defined.
• Rework and reevaluation activities have not been fully documented in the device history record.
• Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established.

All of the companies cited were involved in either Devices or Food and Cosmetics sectors.

All of the 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
Carolina Cookie Company	Food and Cosmetics	10/10/2023	Hazard analysis - Conducted
KALO Foods, LLC	Food and Cosmetics	10/26/2023	Sanitary operations - Plant maintenance
KALO Foods, LLC	Food and Cosmetics	10/26/2023	Pest control
KALO Foods, LLC	Food and Cosmetics	10/26/2023	Process control - Foreign objects
Tex-Care Medical	Devices	12/15/2023	Quality audits - Lack of or inadequate procedures
Tex-Care Medical	Devices	12/15/2023	Documentation
Tex-Care Medical	Devices	12/15/2023	Lack of or inadequate DHR procedures
Thunderbird Molding Greensboro, LLC	Devices	11/17/2023	Supplier oversight
Thunderbird Molding Greensboro, LLC	Devices	11/17/2023	Product rework documentation, DHR {see also 820.184}
Thunderbird Molding Greensboro, LLC	Devices	11/17/2023	Lack of or inadequate complaint procedures