LGM Pharma Solutions
Irvine, California, United States
Program data pending ClinicalTrials.gov matching
Profiled
Not yet scored
✓ FDA Inspections (2)
○ Clinical Trials
○ SEC Filings
○ Press
○ EMA GMP
○ MHRA GMP
Quick Facts: LGM Pharma Solutions
- Signal Score
- Profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed. How scoring works
- Headquarters
- Irvine, California, United States
- Website
- https://lgmpharma.com/cdmo-services/commercial-scale-up-facilities-equipment/
- Modalities
- Oral Solid Dose, Oral Liquids, Semi-solids & Liquids, Finished Dosage Forms, Controlled Substances
- Active Programs
- No ClinicalTrials.gov matches confirmed
- Data Sources
- FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring
About LGM Pharma Solutions
LGM Pharma Solutions is a contract development and manufacturing organization (CDMO). Capabilities: Oral Solid Dose, Oral Liquids, Semi-solids & Liquids, Finished Dosage Forms, Controlled Substances. 3 manufacturing sites registered with the U.S. FDA and Health Canada. Website: https://lgmpharma.com/cdmo-services/commercial-scale-up-facilities-equipment/
Signal Score
Profiled, not yet scored.
Scores are published after regulatory evidence is attached and reviewed.
How scoring works
LGM Pharma Solutions FDA Inspection History
2025-01
2024-03
NAI
VAI
OAI
| Date | Site | Type | Observations | Classification |
|---|---|---|---|---|
| 2025-01-24 |
LGM Pharma Solutions, LLC
Irvine, California
Company-level
|
Bioresearch Monitoring | No | No Action Indicated (NAI) |
| 2024-03-01 |
LGM Pharma Solutions, LLC
Irvine, California
Company-level
|
Drug Quality Assurance | Yes | Voluntary Action Indicated (VAI) |
Source: FDA Data Dashboard · Retrieved Oct 31, 2026
LGM Pharma Solutions FDA 483 Findings 4 observations · 2024-03-01 → 2024-03-01 ?
By subsystem
By severity
- 3 — Moderate: 1
- 2 — Minor: 3
- Repeat observations: 0
Most severe findings
-
Deviations from laboratory control requirements
"Deviations from written test procedures and laboratory mechanisms are not recorded and justified."
-
Procedures not in writing, fully followed
"The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed."
-
Written procedures not established/followed
"Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a 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. This company's careers site asks automated readers not to collect it (robots.txt), and we respect that.
Source:
public careers pages
· Checked Oct 30, 2026
Frequently Asked Questions About LGM Pharma Solutions
How many FDA inspections does LGM Pharma Solutions have on record?
CDMO Signal tracks 2 FDA inspections for LGM Pharma Solutions, sourced from the FDA inspection database. See the full inspection history above.
Has LGM Pharma Solutions received an FDA warning letter?
CDMO Signal has no FDA warning letters on record for LGM Pharma Solutions.
Does LGM Pharma Solutions have a CDMO Signal Score?
Not yet. LGM Pharma Solutions is profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed.
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