There were five companies in cities associated with Alamance County that received FDA citations as a result of five inspections conducted in the county in 2025, according to the U.S. Food and Drug Administration (FDA).
This is a 150% increase over the number of companies cited in the previous year.
The citations in the county include:
- You did not have process control monitoring and corrective action records.
- Your preventive controls records did not meet general records requirements.
- No management representative had been appointed to ensure that quality system requirements are met, and to report to management on the performance of the quality system.
Most of the companies cited were involved in either Food and Cosmetics or Devices sectors.
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 and quality.
| Company Name | Area of Business | Inspection Date | Issue Cited |
|---|---|---|---|
| Carolina Biological Supply Company | Devices | 12/17/2025 | Quality audits – auditor independence |
| Elevate Textiles, Inc. | Devices | 04/11/2025 | Management representative |
| Elevate Textiles, Inc. | Devices | 04/11/2025 | Quality System Procedures |
| Elevate Textiles, Inc. | Devices | 04/11/2025 | Quality Audit/Reaudit – conducted |
| Elevate Textiles, Inc. | Devices | 04/11/2025 | Training records |
| Elevate Textiles, Inc. | Devices | 04/11/2025 | Design history file |
| Elevate Textiles, Inc. | Devices | 04/11/2025 | Lack of or inadequate procedures |
| James Foods, Inc. | Food and Cosmetics | 02/10/2025 | Plant construction and design |
| Randleman Farms | Veterinary | 08/07/2025 | Introduction/delivery into IS – illegal drug residue |
| Randleman Farms | Veterinary | 08/07/2025 | Medication status of animal(s) |
| Star Food Products, Inc. | Food and Cosmetics | 01/22/2025 | Process preventive controls – Implementation records |
| Star Food Products, Inc. | Food and Cosmetics | 01/22/2025 | Preventive controls records – General requirements |



