There was one company in a city associated with Collier County that received FDA citations as a result of one inspection conducted in the county in March, according to the U.S. Food and Drug Administration (FDA).
This is unchanged from the number of companies cited in the previous month.
The citations in the county include:
- A risk-based approach to the control of the appropriate processes needed for the quality management system has not been adequately applied.
- Processes for production and service provision where the resulting output cannot be, or is not, verified by subsequent monitoring or measurement were not validated.
- Evidence of conformity to the acceptance criteria for product monitoring and measurement was not adequately maintained.
The company cited should take a voluntary action to correct its 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 |
|---|---|---|---|
| TriRx Medical, LLC | Devices | 03/06/2026 | Risk-based approach not applied to QMS processes |
| TriRx Medical, LLC | Devices | 03/06/2026 | Process for production and service provision not validated |
| TriRx Medical, LLC | Devices | 03/06/2026 | Evidence of conformity to the acceptance criteria not maintained |
| TriRx Medical, LLC | Devices | 03/06/2026 | Records of nonconforming product and actions taken not maintained |
Information in this article was obtained from the U.S. Food and Drug Administration. The source data can be found here.


