Fareva Amboise
France
Program data pending ClinicalTrials.gov matching
Profiled
Not yet scored
✓ FDA Inspections (1)
○ Clinical Trials
○ SEC Filings
○ Press
✓ EMA GMP (3)
○ MHRA GMP
✓ HC GMP (9)
Quick Facts: Fareva Amboise
- Signal Score
- Profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed. How scoring works
- Headquarters
- France
- Website
- https://www.fareva.com/
- Modalities
- Oral Solid Dose, Semi-solids & Liquids
- Active Programs
- No ClinicalTrials.gov matches confirmed
- Data Sources
- FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring
About Fareva Amboise
Fareva Amboise is a contract development and manufacturing organization (CDMO). Capabilities: Oral Solid Dose, Semi-solids & Liquids. 1 manufacturing site registered with the U.S. FDA and Health Canada. Website: https://www.fareva.com/
Signal Score
Profiled, not yet scored.
Scores are published after regulatory evidence is attached and reviewed.
How scoring works
Fareva Amboise FDA Inspection History
2025-09
NAI
VAI
OAI
| Date | Site | Type | Observations | Classification |
|---|---|---|---|---|
| 2025-09-16 |
Fareva Amboise
Poce Sur Cisse
Company-level
|
Drug Quality Assurance | Yes | Official Action Indicated (OAI) |
Source: FDA Data Dashboard · Retrieved Oct 31, 2026
Fareva Amboise FDA 483 Findings 9 observations · 2025-09-16 → 2025-09-16 ?
By subsystem
By severity
- 5 — Critical: 1
- 4 — Serious: 3
- 2 — Minor: 5
- Repeat observations: 0
Most severe findings
-
Computer control of master formula records
"Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel."
-
Validation lacking for sterile drug products
"Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process."
-
Environmental Monitoring System
"Aseptic processing areas are deficient regarding the system for monitoring environmental conditions."
Fareva Amboise EMA GMP Compliance 3 certificates
2025-10
2025-10
2025-04
Compliant
Non-Compliant
| Certificate | Site | Country | Inspection Date | Status |
|---|---|---|---|---|
| 2026_HPF_FR_007 | Fareva Amboise | France | 2025-10-02 | COMPLIANT |
| 2026_HPF_FR_008 | Fareva Amboise | France | 2025-10-02 | COMPLIANT |
| 25/389926 | Fareva Amboise | France | 2025-04-30 | COMPLIANT |
Source: EMA EudraGMDP · Retrieved Oct 31, 2026
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 Fareva Amboise
How many FDA inspections does Fareva Amboise have on record?
CDMO Signal tracks 1 FDA inspection for Fareva Amboise, sourced from the FDA inspection database. See the full inspection history above.
Has Fareva Amboise received an FDA warning letter?
CDMO Signal has no FDA warning letters on record for Fareva Amboise.
Does Fareva Amboise hold EMA or MHRA GMP certificates?
CDMO Signal tracks 3 EMA GMP certificates for Fareva Amboise.
Does Fareva Amboise have a CDMO Signal Score?
Not yet. Fareva Amboise is profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed.
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