1116338
Perahealth Inc — FEI 3014498723
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 30, 2020
- Fiscal Year
- 2020
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Charlotte, NC (United States)
Citations
| ID | CFR | Description |
|---|
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 2430 | 21 CFR 820.30(b) | Design plans - Lack of or inadequate |
| 3147 | 21 CFR 820.170(a) | Lack of or inadequate instructions |
| 3201 | 21 CFR 820.40(a) | Not approved or obsolete document retrieval |
| 3203 | 21 CFR 820.40(b) | Document change records, maintained. |
| 3409 | 21 CFR 820.200(d) | Service reports |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 3666 | 21 CFR 820.20(c) | Management review - Lack of or inadequate procedures |
| 3837 | 21 CFR 820.25(b) | Training records |
| 3838 | 21 CFR 820.40(a) | Document review procedures, designated individual |
| 4057 | 21 CFR 820.20(a) | Management ensuring quality policy is understood |
| 4061 | 21 CFR 820.20(b)(3)(ii) | Management representative's reports |
| 4070 | 21 CFR 820.30(g) | Design validation - documentation |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |