Reig Jofre CDMO

Sant Joan Despí, Barcelona, Spain
Hybrid — also manufactures internal programs
Sterile Injectables Lyophilization Oral Solid Dose Non-sterile Liquids Clinical Trial Manufacturing
Program data pending ClinicalTrials.gov matching
Profiled
Not yet scored
✓ FDA Inspections (1) ○ Clinical Trials ○ SEC Filings ✓ Press (2) ○ EMA GMP ○ MHRA GMP ✓ HC GMP (10)

Quick Facts: Reig Jofre CDMO

Signal Score
Profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed. How scoring works
Headquarters
Sant Joan Despí, Barcelona, Spain
Website
Modalities
Sterile Injectables, Lyophilization, Oral Solid Dose, Non-sterile Liquids, Clinical Trial Manufacturing
Active Programs
No ClinicalTrials.gov matches confirmed
Data Sources
FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring

About Reig Jofre CDMO

Reig Jofre CDMO makes its own pharmaceutical products and also offers contract development and manufacturing services. Capabilities: Sterile Injectables, Lyophilization, Oral Solid Dose, Non-sterile Liquids, Clinical Trial Manufacturing. 2 manufacturing sites registered with the U.S. FDA and Health Canada. Website: https://reigjofre.com/en/services/cdmo-services

Signal Score

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

Reig Jofre CDMO FDA Inspection History

2023-06
NAI VAI OAI
Date Site Type Observations Classification
2023-06-23
Laboratorio Reig Jofre S.A.
Toledo Company-level
Drug Quality Assurance Yes Official Action Indicated (OAI)
Source: FDA Data Dashboard · Retrieved Oct 31, 2026

Reig Jofre CDMO FDA 483 Findings 7 observations · 2023-06-23 → 2023-06-23 ?

By subsystem

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

By severity

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

Most severe findings

  • Moderate (3) CAPA 2023-06-23 21 CFR 211.198(b)(2)
    Written record of complaint to include findings, follow-up

    "Written records of investigation of a drug complaint do not include the findings of the investigation."

  • Moderate (3) Laboratory Controls 2023-06-23 21 CFR 211.194(a)
    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."

  • Moderate (3) Laboratory Controls 2023-06-23 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."

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

Company Signals 2 articles

Company announcements, not verified evidence. They do not change any score.
news Thu, 11 Ju
Reig Jofre launches dalbavancin in European hospital push - The Pharma Letter
news Sun, 07 De
Reig Jofre takes over Leanbio - The Pharma Letter

Frequently Asked Questions About Reig Jofre CDMO

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