# FDA 483 - TriRx Medical, LLC - March 06, 2026

Source: https://www.keypedia.com/records/483/trirx-medical-llc/6bf8d104-a324-401f-9bad-4110156077a7

> FDA 483 for TriRx Medical, LLC on March 06, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: TriRx Medical, LLC
- Inspection Date: 2026-03-06
- Product Type: device
- Office Name: Florida District Office
- Summary: An FDA inspection of TriRx Medical, LLC in Naples, FL, a manufacturer of orthopedic external fixation medical devices, revealed significant deficiencies in its quality management system. The firm failed to adequately apply a risk-based approach, validate critical manufacturing processes, and maintain proper records for nonconforming products and final inspections. These issues indicate a lack of robust controls over device safety, performance, and regulatory compliance.

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Company: https://www.keypedia.com/companies/trirx-medical-llc/8511fdf1-adba-4f9c-979e-4df3c1ac4c9b

Office: https://www.keypedia.com/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9