There were two companies in cities associated with Collier County that received FDA citations as a result of two inspections conducted in the county over the first quarter of 2026, according to the U.S. Food and Drug Administration (FDA).
No companies were cited in the previous quarter.
The citations in the county include:
- You did not take a reasonable measure or precaution related to personnel practices.
- Your plant did not have adequate sanitary facilities and accommodations.
- You did not take an adequate measure to protect against inclusion of metal or extraneous material in food.
The companies cited were involved in either Food and Cosmetics or Devices sectors.
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.
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 |
|---|---|---|---|
| Ark Foods Group, Inc. | Food and Cosmetics | 02/04/2026 | Personnel |
| Ark Foods Group, Inc. | Food and Cosmetics | 02/04/2026 | Sanitary facilities and controls |
| Ark Foods Group, Inc. | Food and Cosmetics | 02/04/2026 | Process control – Foreign objects |
| 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.


