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

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.