Grifols Partnership (Parenterals CDMO)
Quick Facts: Grifols Partnership (Parenterals CDMO)
- Signal Score
- Profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed. How scoring works
- Headquarters
- Barcelona, Spain
- Website
- https://www.partnership.grifols.com/
- Modalities
- Sterile Injectables, IV Bags, Sterile Fill-Finish
- Active Programs
- No ClinicalTrials.gov matches confirmed
- Data Sources
- FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring
About Grifols Partnership (Parenterals CDMO)
Grifols Partnership (Parenterals CDMO) makes its own pharmaceutical products and also offers contract development and manufacturing services. Capabilities: Sterile Injectables, IV Bags, Sterile Fill-Finish. 2 manufacturing sites registered with the U.S. FDA. Website: https://www.partnership.grifols.com/
Signal Score
Grifols Partnership (Parenterals CDMO) FDA Inspection History
| Date | Site | Type | Observations | Classification |
|---|---|---|---|---|
| 2026-06-19 |
Laboratorios Grifols, S.A.
Parets Del Valles
Company-level
|
Blood and Blood Products | No | No Action Indicated (NAI) |
| 2025-09-10 |
Laboratorios Grifols S.A.
Las Torres De Cotillas
Company-level
|
Drug Quality Assurance | No | Voluntary Action Indicated (VAI) |
| 2024-07-26 |
Laboratorios Grifols, S.A.
Parets Del Valles
Company-level
|
Blood and Blood Products | Yes | Voluntary Action Indicated (VAI) |
| 2023-10-27 |
Laboratorios Grifols, S.A.
Parets Del Valles
Company-level
|
Drug Quality Assurance | No | Voluntary Action Indicated (VAI) |
| 2022-11-10 |
Laboratorios Grifols S.A.
Las Torres De Cotillas
Company-level
|
Drug Quality Assurance | No | Voluntary Action Indicated (VAI) |
Grifols Partnership (Parenterals CDMO) FDA 483 Findings 4 observations · 2024-07-26 → 2024-07-26 ?
By subsystem
By severity
- 3 — Moderate: 1
- 2 — Minor: 3
- Repeat observations: 0
Most severe findings
-
Complete Test Data
"Laboratory records are deficient in that they do not include a complete record of all data obtained during testing."
-
Written procedures fail to include
"Written procedures for cleaning and maintenance fail to include description in sufficient detail of methods, equipment and materials used."
-
Batch production and Batch Control Record Requirements
"The batch production and control records are deficient in that they do not include documentation of the accomplishment of each significant step in manufacturing."