FDA Inspection 1302186 — Grifols Therapeutics LLC
The FDA completed an inspection of Grifols Therapeutics LLC on Feb 5, 2026 in Clayton, NC. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- Feb 5, 2026
- Fiscal Year
- 2026
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Clayton, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 9095 | 21 CFR 600.80(c)(1)(i) | Reporting Requirements - 15-day alert |