There were two companies in cities associated with Alamance County that received FDA citations as a result of two inspections conducted in the county throughout 2023, according to reports from the U.S. Food and Drug Administration (FDA).
This is unchanged from the number of companies cited in the previous year.
The citations in the county include:
- Procedures for quality audits have not been adequately established.
- In-process inspections, tests, or other verification activities and approvals were not documented.
- Procedures for device history records have not been adequately established.
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.
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 |
|---|---|---|---|
| Rolls Enterprises, Inc. | Food and Cosmetics | 01/20/2023 | Process filing |
| 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 |
