Terumo Pharmaceutical Solutions

Tokyo, Japan
Hybrid — also manufactures internal programs
Sterile Fill-Finish Prefilled Syringes
Program data pending ClinicalTrials.gov matching
Profiled
Not yet scored
✓ FDA Inspections (1) ○ Clinical Trials ○ SEC Filings ○ Press ○ EMA GMP ✓ MHRA GMP (1) ✓ HC GMP (3)

Quick Facts: Terumo Pharmaceutical Solutions

Signal Score
Profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed. How scoring works
Headquarters
Tokyo, Japan
Website
Modalities
Sterile Fill-Finish, Prefilled Syringes
Active Programs
No ClinicalTrials.gov matches confirmed
Data Sources
FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring

About Terumo Pharmaceutical Solutions

Terumo Pharmaceutical Solutions makes its own pharmaceutical products and also offers contract development and manufacturing services. Capabilities: Sterile Fill-Finish, Prefilled Syringes. 1 manufacturing site registered with the U.S. FDA, the UK MHRA and Health Canada. Website: https://www.terumopharmaceuticalsolutions.com/

Signal Score

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

Terumo Pharmaceutical Solutions FDA Inspection History

2023-03
NAI VAI OAI
Date Site Type Observations Classification
2023-03-30
TERUMO YAMAGUCHI CORPORATION
Yamaguchi Company-level
Drug Quality Assurance Yes Voluntary Action Indicated (VAI)
Source: FDA Data Dashboard · Retrieved Oct 31, 2026

Terumo Pharmaceutical Solutions FDA 483 Findings 2 observations · 2023-03-30 → 2023-03-30 ?

By subsystem

  • Laboratory Controls 1 (50.0%)
  • Data Integrity 1 (50.0%)

By severity

  • 5 — Critical: 1
  • 3 — Moderate: 1
  • Repeat observations: 0

Most severe findings

  • Critical (5) Data Integrity 2023-03-30 21 CFR 211.68(b)
    Backup data not assured as exact and complete

    "Backup data is not assured as complete and secure from alteration, erasure or loss through keeping hard copy or alternate systems."

  • Moderate (3) Laboratory Controls 2023-03-30 21 CFR 211.84(b)
    Representative Samples

    "Representative samples are not taken of each shipment of each lot of components for testing or examination."

Terumo Pharmaceutical Solutions MHRA GMP Compliance 1 certificates

2018-04
Compliant Non-Compliant
Certificate Site City / Postcode Inspection Date Status
UK GMP 49750 Insp GMP 49750/18408930-0001[H] TERUMO YAMAGUCHI D&D CORPORATION JP-754-0894 2018-04-18 COMPLIANT
Source: MHRA GMDP Database · 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 Terumo Pharmaceutical Solutions

How many FDA inspections does Terumo Pharmaceutical Solutions have on record?
CDMO Signal tracks 1 FDA inspection for Terumo Pharmaceutical Solutions, sourced from the FDA inspection database. See the full inspection history above.
Has Terumo Pharmaceutical Solutions received an FDA warning letter?
CDMO Signal has no FDA warning letters on record for Terumo Pharmaceutical Solutions.
Does Terumo Pharmaceutical Solutions hold EMA or MHRA GMP certificates?
CDMO Signal tracks 1 MHRA GMP certificate for Terumo Pharmaceutical Solutions.
Does Terumo Pharmaceutical Solutions have a CDMO Signal Score?
Not yet. Terumo Pharmaceutical Solutions is profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed.
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