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 first quarter of 2025, 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:
- Your firm failed to have systems in place to enable compliance with the verification requirements of the DSCSA.
- You did not implement your sanitation preventive control procedures.
- You did not review your process preventive control verification records.
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.
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 |
|---|---|---|---|
| Automatic Rolls of North Carolina, LLC | Food and Cosmetics | 02/13/2025 | Sanitation preventive controls – Implement |
| Automatic Rolls of North Carolina, LLC | Food and Cosmetics | 02/13/2025 | Process preventive controls – Record review |
| Automatic Rolls of North Carolina, LLC | Food and Cosmetics | 02/13/2025 | Sanitation preventive controls – Record review |
| Automatic Rolls of North Carolina, LLC | Food and Cosmetics | 02/13/2025 | Record availability |
| United Therapeutics Corporation | Drugs | 02/28/2025 | Systems in place to comply with verifciation requirements |
