1304634
Practicon Inc — FEI 1051614
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 26, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Greenville, NC (United States)
Citations
| ID | CFR | Description |
|---|
| 23061 | ISO 13485:2016 Clause 5.6.1 | QMS not reviewed by top management at documented planned intervals |
| 23072 | ISO 13485:2016 Clause 6.2(b) | Personnel training not provided |
| 23088 | ISO 13485:2016 Clause 7.1 | Records of risk management activities in product realization not maintained |