546844
Fertility Technology Resources, Inc. — FEI 3003889409
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 16, 2008
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Murphy, NC (United States)
Citations
| ID | CFR | Description |
|---|
| 2650 | 21 CFR 820.30(f) | Design verification - Lack of or inadequate procedures |
| 3120 | 21 CFR 820.80(a) | Lack of or inadequate procedures - Acceptance activities |
| 3139 | 21 CFR 820.140 | Lack of or inadequate procedures for handling |
| 3141 | 21 CFR 820.150(a) | Storage procedures to prevent mix-ups |
| 3332 | 21 CFR 820.184(e) | ID label, labeling |
| 3396 | 21 CFR 820.80(d)(1) | DMR required activities {see also 820.181} |
| 3417 | 21 CFR 820.70(a)(2) | Production monitoring and control |
| 3427 | 21 CFR 820.50(a)(2) | Supplier oversight |
| 3671 | 21 CFR 820.25(a) | Personnel |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 4057 | 21 CFR 820.20(a) | Management ensuring quality policy is understood |
| 537 | 21 CFR 820.70(a) | Production processes |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |