1148583
Arch Medical Solutions - Elkhart — FEI 3009923627
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- August 6, 2021
- Fiscal Year
- 2021
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Elkhart, IN (United States)
Citations
| ID | CFR | Description |
|---|
| 3128 | 21 CFR 820.90(a) | Nonconforming product control |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3237 | 21 CFR 820.72(b) | Remedial action |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |