How many FDA citations were issued in cities within Alamance County in 2025

Martin A. Makary, M.D. Commissioner of Food and Drugs of FDA - https://www.fda.gov/
Martin A. Makary, M.D. Commissioner of Food and Drugs of FDA - https://www.fda.gov/
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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.

Companies Located within Alamance County Cities and the Citations They Received in 2025
Company NameArea of BusinessInspection DateIssue Cited
Carolina Biological Supply CompanyDevices12/17/2025Quality audits – auditor independence
Elevate Textiles, Inc.Devices04/11/2025Management representative
Elevate Textiles, Inc.Devices04/11/2025Quality System Procedures
Elevate Textiles, Inc.Devices04/11/2025Quality Audit/Reaudit – conducted
Elevate Textiles, Inc.Devices04/11/2025Training records
Elevate Textiles, Inc.Devices04/11/2025Design history file
Elevate Textiles, Inc.Devices04/11/2025Lack of or inadequate procedures
James Foods, Inc.Food and Cosmetics02/10/2025Plant construction and design
Randleman FarmsVeterinary08/07/2025Introduction/delivery into IS – illegal drug residue
Randleman FarmsVeterinary08/07/2025Medication status of animal(s)
Star Food Products, Inc.Food and Cosmetics01/22/2025Process preventive controls – Implementation records
Star Food Products, Inc.Food and Cosmetics01/22/2025Preventive controls records – General requirements
Information in this article was obtained from the U.S. Food and Drug Administration. The source data can be found here.



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