1118471
Pegasus Research Corporation — FEI 2026969
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 21, 2020
- Fiscal Year
- 2020
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Santa Ana, CA (United States)
Citations
| ID | CFR | Description |
|---|
| 2328 | 21 CFR 820.22 | Quality audits - auditor independence |
| 3101 | 21 CFR 820.30(g) | Design validation- Lack of or inadequate procedures |
| 3233 | 21 CFR 820.72(a) | Calibration, Inspection, etc. Procedures Lack of or Inadequ |
| 3837 | 21 CFR 820.25(b) | Training records |
| 541 | 21 CFR 820.70(c) | Environmental control Lack of or inadequate procedures |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |