Bushu Pharmaceuticals
Kawagoe, Saitama, Japan
Program data pending ClinicalTrials.gov matching
Profiled
Not yet scored
✓ FDA Inspections (3)
○ Clinical Trials
○ SEC Filings
○ Press
○ EMA GMP
○ MHRA GMP
Quick Facts: Bushu Pharmaceuticals
- Signal Score
- Profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed. How scoring works
- Headquarters
- Kawagoe, Saitama, Japan
- Website
- https://www.bushu-pharma.com/en/
- Modalities
- Oral Solid Dose, Sterile Injectables, Clinical Trial Manufacturing, Packaging & Labeling
- Active Programs
- No ClinicalTrials.gov matches confirmed
- Data Sources
- FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring
About Bushu Pharmaceuticals
Bushu Pharmaceuticals is a contract development and manufacturing organization (CDMO). Capabilities: Oral Solid Dose, Sterile Injectables, Clinical Trial Manufacturing, Packaging & Labeling. 2 manufacturing sites registered with the U.S. FDA and Health Canada. Website: https://www.bushu-pharma.com/en/
Signal Score
Profiled, not yet scored.
Scores are published after regulatory evidence is attached and reviewed.
How scoring works
Bushu Pharmaceuticals FDA Inspection History
2026-08
2023-11
2022-12
NAI
VAI
OAI
| Date | Site | Type | Observations | Classification |
|---|---|---|---|---|
| 2026-08-03 |
Bushu Pharmaceuticals Ltd.
Kawagoe
Company-level
|
Drug Quality Assurance | Yes | Voluntary Action Indicated (VAI) |
| 2023-11-10 |
Bushu Pharmaceuticals Ltd
Kodama-Gun
Company-level
|
Drug Quality Assurance | No | No Action Indicated (NAI) |
| 2022-12-02 |
Bushu Pharmaceuticals Ltd.
Kawagoe
Company-level
|
Drug Quality Assurance | Yes | Voluntary Action Indicated (VAI) |
Source: FDA Data Dashboard · Retrieved Oct 31, 2026
Bushu Pharmaceuticals FDA 483 Findings 5 observations · 2022-12-02 → 2026-08-03 ?
By subsystem
By severity
- 3 — Moderate: 2
- 2 — Minor: 3
- Repeat observations: 0
Most severe findings
-
Complete test data included in records
"Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards."
-
Following/documenting laboratory controls
"Established test procedures and laboratory control mechanisms are not followed and documented at the time of performance."
-
Written in-process control procedures
"Written procedures are not established that describe the in-process controls to be conducted on appropriate samples of in-process materials of each batch."
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. This company's careers site asks automated readers not to collect it (robots.txt), and we respect that.
Source:
public careers pages
· Checked Oct 30, 2026
Frequently Asked Questions About Bushu Pharmaceuticals
How many FDA inspections does Bushu Pharmaceuticals have on record?
CDMO Signal tracks 3 FDA inspections for Bushu Pharmaceuticals, sourced from the FDA inspection database. See the full inspection history above.
Has Bushu Pharmaceuticals received an FDA warning letter?
CDMO Signal has no FDA warning letters on record for Bushu Pharmaceuticals.
Does Bushu Pharmaceuticals have a CDMO Signal Score?
Not yet. Bushu Pharmaceuticals is profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed.
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