How many companies in cities across Forsyth County received FDA citations in 2025?

Jim Traficant, Chief of Staff of FDA
Jim Traficant, Chief of Staff of FDA
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There were five companies in cities associated with Forsyth 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 25% increase over the number of companies cited in the previous year.

The citations in the county include:

  • The responsibilities and procedures applicable to the quality control unit are not fully followed.
  • Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
  • The batch production and control records are deficient in that they do not include documentation of the accomplishment of each significant step in manufacturing.

Most of the companies cited were involved in either Drugs 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 Forsyth County Cities and the Citations They Received in 2025
Company NameArea of BusinessInspection DateIssue Cited
Cathtek, LLCDevices02/27/2025Equipment control activity documentation
Cathtek, LLCDevices02/27/2025Documentation
Keranetics, Inc.Devices02/06/2025Lack of Written MDR Procedures
Keranetics, Inc.Devices02/06/2025Management review – defined interval, sufficient frequency
Keranetics, Inc.Devices02/06/2025Quality Audit/Reaudit – conducted
Keranetics, Inc.Devices02/06/2025Lack of or inadequate complaint procedures
Kevin Stein, M.D.Drugs04/23/2025FD-1572, protocol compliance
ThermoFisher ScientificDrugs07/17/2025Procedures not in writing, fully followed
ThermoFisher ScientificDrugs07/17/2025Written procedures not established/followed
ThermoFisher ScientificDrugs07/17/2025Batch production and Batch Control Record Requirements
Tortilla Factory, Inc.Food and Cosmetics03/26/2025Plant construction and design
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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