FDA Inspection 1231969 — Eurofins Donor & Product Testing Inc Dallas
The FDA completed an inspection of Eurofins Donor & Product Testing Inc Dallas on March 5, 2024 in Dallas, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Biologics.
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 |