788418
Physio PS, Inc. — FEI 3000210032
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- June 13, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Londonderry, NH (United States)
Citations
| ID | CFR | Description |
|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 14717 | 21 CFR 820.30(g) | Design validation - software validation documentation |
| 3104 | 21 CFR 820.30(j) | Design history file |
| 4057 | 21 CFR 820.20(a) | Management ensuring quality policy is understood |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |