Lifecore Biomedical

United States
Sterile Fill-Finish
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 (9)

Quick Facts: Lifecore Biomedical

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 Lifecore Biomedical

Lifecore Biomedical is a contract development and manufacturing organization (CDMO). Capabilities: Sterile Fill-Finish. 1 manufacturing site registered with the U.S. FDA and Health Canada. Website: https://www.lifecore.com/

Signal Score

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

Lifecore Biomedical FDA Inspection History

2025-03
NAI VAI OAI
Date Site Type Observations Classification
2025-03-12
Lifecore Biomedical, LLC
Chaska, Minnesota Company-level
Drug Quality Assurance Yes Voluntary Action Indicated (VAI)
Source: FDA Data Dashboard · Retrieved Oct 31, 2026

Lifecore Biomedical FDA 483 Findings 2 observations · 2025-03-12 → 2025-03-12 ?

By subsystem

  • Laboratory Controls 1 (50.0%)
  • Equipment & Facilities 1 (50.0%)

By severity

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

Most severe findings

  • Moderate (3) Laboratory Controls 2025-03-12 21 CFR 211.166(a)
    Written program not followed

    "The written stability testing program is not followed."

  • Minor (2) Equipment & Facilities 2025-03-12 21 CFR 211.67(a)
    Cleaning / Sanitizing / Maintenance

    "Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of 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

Company Signals 2 articles

Company announcements, not verified evidence. They do not change any score.
general 2026-10-23
Is Lifecore Biomedical (LFCR) an Asymmetric Risk-Reward in Pharma Contract Manufacturing? - Yahoo Finance
Is Lifecore Biomedical (LFCR) an Asymmetric Risk-Reward in Pharma Contract Manufacturing?  Yahoo Finance
regulatory 2026-10-07
Lifecore Biomedical to Participate at Upcoming Industry Conferences - GlobeNewswire
Lifecore Biomedical to Participate at Upcoming Industry Conferences  GlobeNewswire

Frequently Asked Questions About Lifecore Biomedical

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