James Alexander Corporation
United States
Program data pending ClinicalTrials.gov matching
Profiled
Not yet scored
✓ FDA Inspections (1)
○ Clinical Trials
○ SEC Filings
○ Press
○ EMA GMP
○ MHRA GMP
✓ HC GMP (1)
Quick Facts: James Alexander Corporation
- Signal Score
- Profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed. How scoring works
- Headquarters
- United States
- Website
- https://www.james-alexander.com/
- Modalities
- Sterile Fill-Finish, Packaging & Labeling
- Active Programs
- No ClinicalTrials.gov matches confirmed
- Data Sources
- FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring
About James Alexander Corporation
James Alexander Corporation is a contract development and manufacturing organization (CDMO). Capabilities: Sterile Fill-Finish, Packaging & Labeling. 1 manufacturing site registered with the U.S. FDA and Health Canada. Website: https://www.james-alexander.com/
Signal Score
Profiled, not yet scored.
Scores are published after regulatory evidence is attached and reviewed.
How scoring works
James Alexander Corporation FDA Inspection History
2025-02
NAI
VAI
OAI
| Date | Site | Type | Observations | Classification |
|---|---|---|---|---|
| 2025-02-10 |
James Alexander Corp.
Blairstown, New Jersey
Company-level
|
Drug Quality Assurance | No | No Action Indicated (NAI) |
Source: FDA Data Dashboard · Retrieved Oct 31, 2026
James Alexander Corporation FDA 483 Findings 5 observations · 2024-10-24 → 2024-10-24 ?
By subsystem
By severity
- 4 — Serious: 1
- 3 — Moderate: 1
- 2 — Minor: 3
- Repeat observations: 0
Most severe findings
-
Lack of or inadequate process validation
"A process whose results cannot be fully verified by subsequent inspection and test has not been adequately validated according to established procedures."
-
Lack of or inadequate procedures
"Procedures for corrective and preventive action have not been established."
-
Purchasing controls, Lack of or inadequate procedures
"Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been adequately established."
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 James Alexander Corporation
How many FDA inspections does James Alexander Corporation have on record?
CDMO Signal tracks 1 FDA inspection for James Alexander Corporation, sourced from the FDA inspection database. See the full inspection history above.
Has James Alexander Corporation received an FDA warning letter?
CDMO Signal has no FDA warning letters on record for James Alexander Corporation.
Does James Alexander Corporation have a CDMO Signal Score?
Not yet. James Alexander Corporation is profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed.
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