# United Orthopedic Corp. – FDA 483, Sep 9, 2026

Source: https://www.keypedia.com/records/483/united-orthopedic-corp/c69d9a07-5d77-428b-b61e-f4be8d3a6f83

> FDA 483 for United Orthopedic Corp. on September 09, 2026. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: United Orthopedic Corp.
- Inspection Date: 2026-09-09
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Operations
- Summary: United Orthopedic Corp. in Kachsiung, Taiwan, a medical device manufacturer, was cited for significant deficiencies during an FDA inspection. The firm failed to timely submit Medical Device Reports (MDRs) for several serious adverse events, including patient death and infection, and device breakages. Additionally, the company's quality management system software, a spreadsheet used for critical quality records, was not validated for its intended use, raising concerns about data integrity and control.

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/roy-baby/69a18ef5-167c-41eb-a57e-3d138a0820c2)

Company: https://www.keypedia.com/companies/united-orthopedic-corp/00c2ad4d-4bb7-4de7-9845-a8f26ccaee7a

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-operations/27658190-735a-443e-9087-3534cfe74fd4