Uniao Quimica (Outsourcing)

São Paulo, Brazil
Hybrid — also manufactures internal programs
Sterile Injectables Veterinary Oral Solid Dose Semi-solids & Liquids
Program data pending ClinicalTrials.gov matching
Profiled
Not yet scored
○ FDA Inspections ○ Clinical Trials ○ SEC Filings ○ Press ○ EMA GMP ○ MHRA GMP ✓ HC GMP (2)

Quick Facts: Uniao Quimica (Outsourcing)

Signal Score
Profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed. How scoring works
Headquarters
São Paulo, Brazil
Website
Modalities
Sterile Injectables, Veterinary, Oral Solid Dose, Semi-solids & Liquids
Active Programs
No ClinicalTrials.gov matches confirmed
Data Sources
FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring

About Uniao Quimica (Outsourcing)

Uniao Quimica (Outsourcing) makes its own pharmaceutical products and also offers contract development and manufacturing services. Capabilities: Sterile Injectables, Veterinary, Oral Solid Dose, Semi-solids & Liquids. 1 manufacturing site registered with the U.S. FDA and Health Canada. Website: https://www.uniaoquimica.com.br/

Signal Score

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

Uniao Quimica (Outsourcing) FDA 483 Findings 2 observations · 2023-08-09 → 2023-08-09 ?

By subsystem

  • Documentation & Records 1 (50.0%)
  • CAPA 1 (50.0%)

By severity

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

Most severe findings

  • Moderate (3) CAPA 2023-08-09 21 CFR 211.198(a)
    Complaints reviewed by Quality Control Unit

    "Written procedures describing the handling of complaints do not include provisions for review by the quality control unit of any complaint involving the possible failure of a drug product to meet any of its specifications, a determination as to the need for an investigation of any unexplained discrepancy and explaining the reasons for the failure of the batch or any of its components to meet specifications."

  • Minor (2) Documentation & Records 2023-08-09 21 CFR 211.110(a)
    Control procedures to monitor and validate performance

    "Control procedures are not established which monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product."

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 Uniao Quimica (Outsourcing)

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