There were three companies in cities associated with Wake County that received FDA citations as a result of three inspections conducted in the county over the second quarter of 2025, according to reports from the U.S. Food and Drug Administration (FDA).
This is unchanged from the number of companies cited in the previous quarter.
Of the nine citations issued, the most common citation was ‘You did not establish written procedures for holding and distributing operations’.
Most of the companies cited were involved in the Food and Cosmetics 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.
According to its website, 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.
| Company Name | Area of Business | Inspection Date | Issue Cited |
|---|---|---|---|
| Cancer Diagnostics, Inc. | Devices | 04/04/2025 | Management review – Lack of or inadequate procedures |
| Cancer Diagnostics, Inc. | Devices | 04/04/2025 | Quality audits – Lack of or inadequate procedures |
| Cancer Diagnostics, Inc. | Devices | 04/04/2025 | Design control – no procedures |
| Cancer Diagnostics, Inc. | Devices | 04/04/2025 | Purchasing controls, Lack of or inadequate procedures |
| Cancer Diagnostics, Inc. | Devices | 04/04/2025 | Lack of or inadequate procedures |
| Cancer Diagnostics, Inc. | Devices | 04/04/2025 | Maintained |
| Uustar Corporation | Food and Cosmetics | 04/25/2025 | Written procedures – establish; holding and distribution |
| Woho Natural, Inc. | Food and Cosmetics | 04/25/2025 | Personnel – records – written procedures and training |
| Woho Natural, Inc. | Food and Cosmetics | 04/25/2025 | Written procedures – establish; holding and distribution |
