FDA Inspection 1244733 — Laboratorios Grifols, S.A.
The FDA completed an inspection of Laboratorios Grifols, S.A. on July 26, 2024 in Parets Del Valles. 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
- July 26, 2024
- Fiscal Year
- 2024
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Parets Del Valles (Spain)
Citations
| ID | CFR | Description |
|---|---|---|
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 2012 | 21 CFR 211.188(b) | Batch production and Batch Control Record Requirements |
| 2401 | 21 CFR 211.194(a)(4) | Complete Test Data |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |