1303142
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- February 13, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Plymouth, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23016 | ISO 13485:2016 Clause 4.1.1 | QMS not documented and maintained adequately |
| 23169 | ISO 13485:2016 Clause 7.5.6 | Procedures for validation of processes not documented |