FDA Inspection 1289592 — Grifols Diagnostic Solutions, Inc.
The FDA completed an inspection of Grifols Diagnostic Solutions, Inc. on October 31, 2025 in Emeryville, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 31, 2025
- Fiscal Year
- 2026
- Product Type
- Biologics
- Project Area
- Bioresearch Monitoring
- Location
- Emeryville, CA (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 7411 | 21 CFR 312.53(c)(1) | Investigator statement (FDA 1572) |