Hänseler
Herisau, Switzerland
Hybrid — also manufactures internal programs
Program data pending ClinicalTrials.gov matching
Profiled
Not yet scored
✓ FDA Inspections (2)
○ Clinical Trials
○ SEC Filings
○ Press
○ EMA GMP
○ MHRA GMP
Quick Facts: Hänseler
- Signal Score
- Profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed. How scoring works
- Headquarters
- Herisau, Switzerland
- Website
- https://www.haenseler.ch/en/competences/cdmo-portfolio/
- Modalities
- Semi-solids & Liquids, Oral Liquids, Packaging & Labeling
- Active Programs
- No ClinicalTrials.gov matches confirmed
- Data Sources
- FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring
About Hänseler
Hänseler makes its own pharmaceutical products and also offers contract development and manufacturing services. Capabilities: Semi-solids & Liquids, Oral Liquids, Packaging & Labeling. 1 manufacturing site registered with the U.S. FDA. Website: https://www.haenseler.ch/en/competences/cdmo-portfolio/
Signal Score
Profiled, not yet scored.
Scores are published after regulatory evidence is attached and reviewed.
How scoring works
Hänseler FDA Inspection History
2025-09
2022-10
NAI
VAI
OAI
| Date | Site | Type | Observations | Classification |
|---|---|---|---|---|
| 2025-09-04 |
Hanseler AG
Herisau
Company-level
|
Drug Quality Assurance | No | Voluntary Action Indicated (VAI) |
| 2022-10-21 |
Hanseler AG
Herisau
Company-level
|
Drug Quality Assurance | Yes | Voluntary Action Indicated (VAI) |
Source: FDA Data Dashboard · Retrieved Oct 31, 2026
Hänseler FDA 483 Findings 4 observations · 2022-10-21 → 2022-10-21 ?
By subsystem
By severity
- 3 — Moderate: 2
- 2 — Minor: 2
- Repeat observations: 0
Most severe findings
-
Investigations of discrepancies, failures
"There is a failure to thoroughly review whether or not the batch has been already distributed."
-
Component written specification
"Component testing is deficient in that each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality."
-
Control procedures to monitor and validate performance
"Control procedures are not established which validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the 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 Hänseler
How many FDA inspections does Hänseler have on record?
CDMO Signal tracks 2 FDA inspections for Hänseler, sourced from the FDA inspection database. See the full inspection history above.
Has Hänseler received an FDA warning letter?
CDMO Signal has no FDA warning letters on record for Hänseler.
Does Hänseler have a CDMO Signal Score?
Not yet. Hänseler is profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed.
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