ScinoPharm Taiwan

Taiwan
Hybrid — also manufactures internal programs
Small Molecule API Peptides & Oligos Sterile Fill-Finish
Program data pending ClinicalTrials.gov matching
Profiled
Not yet scored
✓ FDA Inspections (2) ○ Clinical Trials ○ SEC Filings ○ Press ○ EMA GMP ○ MHRA GMP ✓ HC GMP (8)

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
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

Profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed. How scoring works

ScinoPharm Taiwan FDA Inspection History

2026-06
2022-10
NAI VAI OAI
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)
Source: FDA Data Dashboard · Retrieved Oct 31, 2026

ScinoPharm Taiwan FDA 483 Findings 7 observations · 2026-06-23 → 2026-06-23 ?

By subsystem

  • Other 2 (28.6%)
  • Personnel & Training 1 (14.3%)
  • Laboratory Controls 1 (14.3%)
  • Environmental Monitoring 1 (14.3%)
  • Documentation & Records 1 (14.3%)
  • CAPA 1 (14.3%)

By severity

  • 4 — Serious: 1
  • 3 — Moderate: 2
  • 2 — Minor: 4
  • Repeat observations: 0

Most severe findings

  • Serious (4) Environmental Monitoring 2026-06-23 21 CFR 211.113(b)
    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."

  • Moderate (3) Laboratory Controls 2026-06-23 21 CFR 211.160(b)
    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."

  • Moderate (3) CAPA 2026-06-23 21 CFR 211.192
    Investigations of discrepancies, failures

    "There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed."

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 ScinoPharm Taiwan

How many FDA inspections does ScinoPharm Taiwan have on record?
CDMO Signal tracks 2 FDA inspections for ScinoPharm Taiwan, sourced from the FDA inspection database. See the full inspection history above.
Has ScinoPharm Taiwan received an FDA warning letter?
CDMO Signal has no FDA warning letters on record for ScinoPharm Taiwan.
Does ScinoPharm Taiwan have a CDMO Signal Score?
Not yet. ScinoPharm Taiwan is profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed.
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