1301490
CAREstream Medical Ltd — FEI 3010396502
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 6, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Lake Mary, FL (United States)
Citations
| ID | CFR | Description |
|---|
| 22795 | 21 CFR 801.20(a) | Label to bear a unique device identifier |
| 23016 | ISO 13485:2016 Clause 4.1.1 | QMS not documented and maintained adequately |
| 23050 | ISO 13485:2016 Clause 5.2 | Top management did not ensure requirements are determined and met |
| 23098 | ISO 13485:2016 Clause 7.3.1 | Design and development procedures not documented |
| 23145 | ISO 13485:2016 Clause 7.4.1 | Records of supplier (re)evaluation, selection, and monitoring not maintained |
| 23172 | ISO 13485:2016 Clause 7.5.6 | Computer software used in production and service provision not validated |
| 23214 | ISO 13485:2016 Clause 8.2.2 | Complaint handling procedures not documented |