Quality Chemical Laboratories
Wilmington, North Carolina, United States
Hybrid — also manufactures internal programs
Program data pending ClinicalTrials.gov matching
Profiled
Not yet scored
✓ FDA Inspections (2)
○ Clinical Trials
○ SEC Filings
○ Press
○ EMA GMP
○ MHRA GMP
✓ HC GMP (9)
Quick Facts: Quality Chemical Laboratories
- Signal Score
- Profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed. How scoring works
- Headquarters
- Wilmington, North Carolina, United States
- Website
- https://qualitychemlabs.com/
- Modalities
- Clinical Trial Manufacturing, Oral Solid Dose, Sterile Fill-Finish, Lyophilization
- Active Programs
- No ClinicalTrials.gov matches confirmed
- Data Sources
- FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring
About Quality Chemical Laboratories
Quality Chemical Laboratories makes its own pharmaceutical products and also offers contract development and manufacturing services. Capabilities: Clinical Trial Manufacturing, Oral Solid Dose, Sterile Fill-Finish, Lyophilization. 1 manufacturing site registered with the U.S. FDA. Website: https://qualitychemlabs.com/
Signal Score
Profiled, not yet scored.
Scores are published after regulatory evidence is attached and reviewed.
How scoring works
Quality Chemical Laboratories FDA Inspection History
2025-07
2024-11
NAI
VAI
OAI
| Date | Site | Type | Observations | Classification |
|---|---|---|---|---|
| 2025-07-24 |
Quality Chemical Laboratories
Wilmington, North Carolina
Company-level
|
Vaccines and Allergenic Products | No | No Action Indicated (NAI) |
| 2024-11-20 |
Quality Chemical Laboratories
Wilmington, North Carolina
Company-level
|
Drug Quality Assurance | Yes | Voluntary Action Indicated (VAI) |
Source: FDA Data Dashboard · Retrieved Oct 31, 2026
Quality Chemical Laboratories FDA 483 Findings 2 observations · 2024-11-20 → 2024-11-20 ?
By subsystem
By severity
- 3 — Moderate: 1
- 2 — Minor: 1
- Repeat observations: 0
Most severe findings
-
Written record of investigation incomplete
"Written records of investigations into the failure of a batch or any of its components to meet specifications do not include the conclusions and follow-up."
-
Equipment Design, Size and Location
"Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use."
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 Quality Chemical Laboratories
How many FDA inspections does Quality Chemical Laboratories have on record?
CDMO Signal tracks 2 FDA inspections for Quality Chemical Laboratories, sourced from the FDA inspection database. See the full inspection history above.
Has Quality Chemical Laboratories received an FDA warning letter?
CDMO Signal has no FDA warning letters on record for Quality Chemical Laboratories.
Does Quality Chemical Laboratories have a CDMO Signal Score?
Not yet. Quality Chemical Laboratories is profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed.
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