FDA Inspection 1253795 — Eurofins Donor & Product Testing, Inc. Atlanta
The FDA completed an inspection of Eurofins Donor & Product Testing, Inc. Atlanta on Nov 5, 2024 in Marietta, GA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 5, 2024
- Fiscal Year
- 2025
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Marietta, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12320 | 21 CFR 1271.160(b)(3) | Actions verified, short and long term solutions |
| 12370 | 21 CFR 1271.200(c) | Calibration procedures and schedules (general) |