600721
Arnold Tuber Industries, LLC — FEI 3003988575
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- July 30, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Orchard Park, NY (United States)
Citations
| ID | CFR | Description |
|---|
| 2269 | 21 CFR 820.20(a) | Quality policy and objectives |
| 2279 | 21 CFR 820.20(b)(2) | Resources |
| 2302 | 21 CFR 820.20(e) | Quality System Procedures |
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3119 | 21 CFR 820.75(b) | Lack/Inad procedure-Monitoring/Control of Validated Proces |
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 3155 | 21 CFR 820.181(a) | DMR device specifications |
| 3159 | 21 CFR 820.184 | DHR content |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3227 | 21 CFR 820.70(g)(1) | Activity documentation |
| 3291 | 21 CFR 820.100(b) | Procedures |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 3432 | 21 CFR 820.75(b)(2) | Documentation of validated process performance |
| 3664 | 21 CFR 820.20(b)(2) | Training |
| 3665 | 21 CFR 820.20(b)(3) | Management representative |
| 3669 | 21 CFR 820.20(c) | Management review - defined interval, sufficient frequency |
| 3684 | 21 CFR 820.75(a) | Documentation - specific items |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 4058 | 21 CFR 820.20 | Management responsibility |
| 4189 | 21 CFR 820.198(a) | General |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |