Fresenius Kabi USA (Contract Manufacturing)

United States
Hybrid — also manufactures internal programs
Sterile Fill-Finish
Program data pending ClinicalTrials.gov matching
Profiled
Not yet scored
✓ FDA Inspections (1) ○ Clinical Trials ○ SEC Filings ✓ Press (7) ○ EMA GMP ○ MHRA GMP

Quick Facts: Fresenius Kabi USA (Contract Manufacturing)

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

About Fresenius Kabi USA (Contract Manufacturing)

Fresenius Kabi USA (Contract Manufacturing) makes its own pharmaceutical products and also offers contract development and manufacturing services. Capabilities: Sterile Fill-Finish. 3 manufacturing sites registered with the U.S. FDA, the UK MHRA and Health Canada. Website: https://cmo.fresenius-kabi.com/

Signal Score

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

Fresenius Kabi USA (Contract Manufacturing) FDA Inspection History

2025-01
NAI VAI OAI
Date Site Type Observations Classification
2025-01-24
Fresenius Kabi AB
Uppsala Facility-linked
Drug Quality Assurance No Voluntary Action Indicated (VAI)
Source: FDA Data Dashboard · 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

Company Signals 7 articles

Company announcements, not verified evidence. They do not change any score.
news Wed, 21 Ja
Fresenius Kabi & TQ Therapeutics join forces to accelerate cell & gene therapy manufacturing - Indian Pharma Post
news Wed, 14 Ja
Fresenius Kabi, TQ Therapeutics Announce Cell Therapy Technology Agreement - Business Wire
news Wed, 14 Ja
Faster to the bedside: Collaboration in cell therapy of Fresenius Kabi and TQ Therapeutics - European Biotechnology Magazine
news Thu, 28 Au
Fresenius debuts European consortium to pursue bedside CAR-T production - Fierce Pharma
news Thu, 22 Ja
Cellular Origins, Fresenius Kabi Tout Automation Milestone in Scaling CGT Manufacturing - Contract Pharma
news Thu, 17 Oc
Fresenius Kabi and Cellular Origins link for CGT manufacture - Pharmaceutical Technology
news Fri, 23 Ja
Milestone Reached in Cell and Gene Therapy Robotic Automation and Manufacturing Collaboration - Genetic Engineering and Biotechnology News

Frequently Asked Questions About Fresenius Kabi USA (Contract Manufacturing)

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