635556
D.T. Davis Enterprises Ltd. — FEI 3001600982
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 5, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Allentown, PA (United States)
Citations
| ID | CFR | Description |
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 3157 | 21 CFR 820.181(c) | DMR QA procedures and specifications |
| 3170 | 21 CFR 820.198(b) | Review and evaluation for investigation |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 3428 | 21 CFR 820.50(a)(3) | Acceptable supplier records |
| 3669 | 21 CFR 820.20(c) | Management review - defined interval, sufficient frequency |
| 4189 | 21 CFR 820.198(a) | General |