FDA Inspection 1328042 — The University Of Texas MD Anderson Cancer Center, Department Of Radiation Physics, Division Of Radiation Oncology
The FDA completed an inspection of The University Of Texas MD Anderson Cancer Center, Department Of Radiation Physics, Division Of Radiation Oncology on Jul 27, 2026 in Houston, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 9 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 27, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Houston, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23061 | ISO 13485:2016 Clause 5.6.1 | QMS not reviewed by top management at documented planned intervals |
| 23117 | ISO 13485:2016 Clause 7.3.6 | Inadequate design and development verification for interfaced device |
| 23119 | ISO 13485:2016 Clause 7.3.7 | Design and development validation not performed as planned |
| 23133 | ISO 13485:2016 Clause 7.3.9 | Requirements for design and development changes not met before implementation |
| 23150 | ISO 13485:2016 Clause 7.4.3 | Purchased product verification activities not established or implemented |
| 23171 | ISO 13485:2016 Clause 7.5.6 | Procedures for production/service provision software validation not documented |
| 23217 | ISO 13485:2016 Clause 8.2.2 | Correction or corrective action resulting from complaint handling not documented |
| 23220 | ISO 13485:2016 Clause 8.2.4 | Internal audits not conducted to ensure QMS meets requirements and is effective |
| 23258 | ISO 13485:2016 Clause 8.5.2 | Corrective action procedures not documented |