1303440
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- February 5, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Okeechobee, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23219 | ISO 13485:2016 Clause 8.2.2 | Complaint handling records not maintained |
| 23248 | ISO 13485:2016 Clause 8.3.4 | Rework records not maintained |
| 23258 | ISO 13485:2016 Clause 8.5.2 | Corrective action procedures not documented |