Burlington Reporter

There were eight companies in cities associated with Guilford County that received FDA citations as a result of eight inspections conducted in the county throughout 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 300% increase over the number of companies cited in the previous year.

Of the 23 citations issued, the most common citation was 'You did not maintain your plant in a clean and sanitary condition and in adequate repair'.

Most of the companies cited were involved in the Food and Cosmetics sector. The second most common type of company cited in the time period worked in the the Devices sector.

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
Gold Medal Products - Carolina Division	Food and Cosmetics	08/16/2023	Plant construction and design
Gold Medal Products - Carolina Division	Food and Cosmetics	08/16/2023	Sanitary operations - Plant maintenance
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
The Procter & Gamble Company	Drugs	03/10/2023	Representative Samples
The Procter & Gamble Company	Drugs	03/10/2023	SOPs not followed / documented
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
Vistar of Greensboro	Food and Cosmetics	07/31/2023	Sanitary operations - Plant maintenance
Vistar of Greensboro	Food and Cosmetics	07/31/2023	Storage and Distribution
WEG Surgical Solutions	Devices	03/08/2023	Management review - Lack of or inadequate procedures
WEG Surgical Solutions	Devices	03/08/2023	Quality Audit/Reaudit - conducted
WEG Surgical Solutions	Devices	03/08/2023	Training - Lack of or inadequate procedures
WEG Surgical Solutions	Devices	03/08/2023	Design control - no procedures
WEG Surgical Solutions	Devices	03/08/2023	Procedures not adequately established or maintained
WEG Surgical Solutions	Devices	03/08/2023	Lack of or inadequate procedures
WEG Surgical Solutions	Devices	03/08/2023	Complaints