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 |
