ScinoPharm Taiwan
Quick Facts: ScinoPharm Taiwan
- Signal Score
- Profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed. How scoring works
- Headquarters
- Taiwan
- Website
- https://www.scinopharm.com/tw/
- Modalities
- Small Molecule API, Peptides & Oligos, Sterile Fill-Finish
- Active Programs
- No ClinicalTrials.gov matches confirmed
- Data Sources
- FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring
About ScinoPharm Taiwan
ScinoPharm Taiwan makes its own pharmaceutical products and also offers contract development and manufacturing services. Capabilities: Small Molecule API, Peptides & Oligos, Sterile Fill-Finish. 1 manufacturing site registered with the U.S. FDA and Health Canada. Website: https://www.scinopharm.com/tw/
Signal Score
ScinoPharm Taiwan FDA Inspection History
| Date | Site | Type | Observations | Classification |
|---|---|---|---|---|
| 2026-06-23 |
Scinopharm Taiwan, Ltd.
Tainan City
Company-level
|
Drug Quality Assurance | Yes | Official Action Indicated (OAI) |
| 2022-10-25 |
Scinopharm Taiwan, Ltd.
Tainan City
Company-level
|
Drug Quality Assurance | No | No Action Indicated (NAI) |
ScinoPharm Taiwan FDA 483 Findings 7 observations · 2026-06-23 → 2026-06-23 ?
By subsystem
By severity
- 4 — Serious: 1
- 3 — Moderate: 2
- 2 — Minor: 4
- Repeat observations: 0
Most severe findings
-
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 and sterilization process."
-
Scientifically sound laboratory controls
"Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity."
-
Investigations of discrepancies, failures
"There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed."