1020072
Custom Assemblies, Inc. — FEI 3000718854
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- July 31, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Pine Level, NC (United States)
Citations
| ID | CFR | Description |
|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 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 |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 3671 | 21 CFR 820.25(a) | Personnel |
| 3686 | 21 CFR 820.90(b)(2) | Product rework documentation, DHR {see also 820.184} |
| 539 | 21 CFR 820.70(b) | Production and Process Change Procedures, lack of or Inad. |
| 635 | 21 CFR 803.17(b)(1) | Info evaluated to determine if event was reportable |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |