Kedrion Biopharma
Italy (Barga / Bolognana, Lucca); USA (Melville, NY)
Hybrid — also manufactures internal programs
Program data pending ClinicalTrials.gov matching
Profiled
Not yet scored
✓ FDA Inspections (3)
○ Clinical Trials
○ SEC Filings
○ Press
○ EMA GMP
○ MHRA GMP
✓ HC GMP (5)
Quick Facts: Kedrion Biopharma
- Signal Score
- Profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed. How scoring works
- Headquarters
- Italy (Barga / Bolognana, Lucca); USA (Melville, NY)
- Website
- https://www.kedrion.com/
- Modalities
- Biologics, Sterile Fill-Finish
- Active Programs
- No ClinicalTrials.gov matches confirmed
- Data Sources
- FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring
About Kedrion Biopharma
Kedrion Biopharma makes its own pharmaceutical products and also offers contract development and manufacturing services. Capabilities: Biologics, Sterile Fill-Finish. 3 manufacturing sites registered with the U.S. FDA and Health Canada. Website: https://www.kedrion.com/
Signal Score
Profiled, not yet scored.
Scores are published after regulatory evidence is attached and reviewed.
How scoring works
Kedrion Biopharma FDA Inspection History
2025-04
2024-03
2022-06
NAI
VAI
OAI
| Date | Site | Type | Observations | Classification |
|---|---|---|---|---|
| 2025-04-30 |
Kedrion S.p.A.
Barga
Company-level
|
Bioresearch Monitoring | No | No Action Indicated (NAI) |
| 2024-03-27 |
Kedrion Biopharma Inc.
Melville, New York
Company-level
|
Blood and Blood Products | No | Voluntary Action Indicated (VAI) |
| 2022-06-24 |
Kedrion S.p.A.
Gallicano
Company-level
|
Blood and Blood Products | Yes | Voluntary Action Indicated (VAI) |
Source: FDA Data Dashboard · Retrieved Oct 31, 2026
Kedrion Biopharma FDA 483 Findings 3 observations · 2022-06-24 → 2022-06-24 ?
By subsystem
By severity
- 2 — Minor: 3
- Repeat observations: 0
Most severe findings
-
Calibration/Inspection/Checking not done
"Routine inspection and checking of mechanical equipment is not performed according to a written program designed to assure proper performance."
-
Absence of Written Procedures
"There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess."
-
Written procedures not established/followed
"Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product."
Hiring Activity Beta
Built from public job postings when a company's own roles can be read. Job postings are signals, not statements by the company; each one below links to the original. How we collect this
No hiring data yet. We haven't found a public jobs feed for this company.
Source:
public careers pages
· Checked Oct 30, 2026
Frequently Asked Questions About Kedrion Biopharma
How many FDA inspections does Kedrion Biopharma have on record?
CDMO Signal tracks 3 FDA inspections for Kedrion Biopharma, sourced from the FDA inspection database. See the full inspection history above.
Has Kedrion Biopharma received an FDA warning letter?
CDMO Signal has no FDA warning letters on record for Kedrion Biopharma.
Does Kedrion Biopharma have a CDMO Signal Score?
Not yet. Kedrion Biopharma is profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed.
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