FDA Inspection 1327408 — Transamerican Technologies International
The FDA completed an inspection of Transamerican Technologies International on Jul 22, 2026 in San Ramon, CA. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Jul 22, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- San Ramon, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23019 | ISO 13485:2016 Clause 4.1.2 | Risk-based approach not applied to QMS processes |
| 23116 | ISO 13485:2016 Clause 7.3.6 | Design and development verification plans not adequate |