1231969
Eurofins Donor & Product Testing Inc Dallas — FEI 3011580036
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 5, 2024
- Fiscal Year
- 2024
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Dallas, TX (United States)
Citations
| ID | CFR | Description |
|---|
| 12288 | 21 CFR 1271.80(c) | Manufacturer instructions not followed |
| 12320 | 21 CFR 1271.160(b)(3) | Actions verified, short and long term solutions |
| 12325 | 21 CFR 1271.160(b)(6) | Deviations--evaluation, cause, corrective action |
| 12367 | 21 CFR 1271.200(a) | Design appropriate, suitably located |