FDA Inspection 1275975 — Eurofins Donor & Product Testing, LLC, San Ramon
The FDA completed an inspection of Eurofins Donor & Product Testing, LLC, San Ramon on Jul 18, 2025 in San Ramon, CA. 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). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 18, 2025
- Fiscal Year
- 2025
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- San Ramon, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12288 | 21 CFR 1271.80(c) | Manufacturer instructions not followed |
| 12436 | 21 CFR 1271.270(a) | Accurate, indelible, legible |
| 12437 | 21 CFR 1271.270(a) | Records incomplete |
| 12443 | 21 CFR 1271.270(d) | Retention time (10 year rules) |