Quotient Sciences - Philadelphia
Quick Facts: Quotient Sciences - Philadelphia
- 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.quotientsciences.com/
- Modalities
- Small Molecule API, Oral Solid Dose
- Active Programs
- No ClinicalTrials.gov matches confirmed
- Data Sources
- FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring
About Quotient Sciences - Philadelphia
Quotient Sciences - Philadelphia is a contract development and manufacturing organization (CDMO). Capabilities: Small Molecule API, Oral Solid Dose. 2 manufacturing sites registered with the U.S. FDA and Health Canada. Website: https://www.quotientsciences.com/
Signal Score
Quotient Sciences - Philadelphia FDA Inspection History
| Date | Site | Type | Observations | Classification |
|---|---|---|---|---|
| 2025-09-17 |
Quotient Sciences - Philadelphia, LLC
Boothwyn, Pennsylvania
Company-level
|
Drug Quality Assurance | Yes | Voluntary Action Indicated (VAI) |
| 2022-12-22 |
Quotient Sciences - Philadelphia, LLC
Boothwyn, Pennsylvania
Company-level
|
Drug Quality Assurance | Yes | Voluntary Action Indicated (VAI) |
Quotient Sciences - Philadelphia FDA 483 Findings 4 observations · 2022-12-22 → 2025-09-17 ?
By subsystem
By severity
- 2 — Minor: 4
- Repeat observations: 1
Most severe findings
-
Cleaning / Sanitizing / Maintenance
"Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product."
-
Written procedures not established/followed
"Written procedures are not followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product."
-
Protective Apparel Not Worn
"Protective apparel is not worn as necessary to protect drug products from contamination."