FDA 483 - Transamerican Technologies International - July 22, 2026

Transamerican Technologies International in San Ramon, CA, a medical device manufacturer, was cited for significant deficiencies in its quality management system during an FDA inspection. The firm failed to implement a risk-based approach for corrective and preventive actions, leading to inadequate risk assessments for nonconforming products. Additionally, the inspection revealed a lack of documented evidence for design and development verification activities for its medical devices.