932468
St. Jude Medical — FEI 3004936110
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- June 26, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Atlanta, GA (United States)
Citations
| ID | CFR | Description |
|---|
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 2338 | 21 CFR 820.22 | Quality audit - audit report review |
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3113 | 21 CFR 820.70(g) | Equipment design and installation |
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3269 | 21 CFR 820.80(b) | Incoming acceptance records, documentation |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 447 | 21 CFR 820.40 | Lack of procedures, or not maintained |
| 537 | 21 CFR 820.70(a) | Production processes |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |