FDA Inspection 1223732 — Instituto Grifols, S.A.
The FDA completed an inspection of Instituto Grifols, S.A. on November 17, 2023 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). 5 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 17, 2023
- 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 |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |