# FDA 483 - Transamerican Technologies International - July 22, 2026

Source: https://www.keypedia.com/records/483/transamerican-technologies-international/1e47db16-a0a5-4f05-abc3-84c4e44343bf

> FDA 483 for Transamerican Technologies International on July 22, 2026. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Transamerican Technologies International
- Inspection Date: 2026-07-22
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: 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.

## Related Officers

- [Kevin T. Le](https://www.keypedia.com/people/kevin-t-le/cf8b5086-f585-4dd5-9f5c-f082b8a340f4)

Company: https://www.keypedia.com/companies/transamerican-technologies-international/9a2ee240-665d-45ce-8fc3-f4b695161d35

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b