Societal CDMO Gainesville (Bend Bioscience)
United States
Program data pending ClinicalTrials.gov matching
Profiled
Not yet scored
✓ FDA Inspections (3)
○ Clinical Trials
○ SEC Filings
✓ Press (10)
○ EMA GMP
○ MHRA GMP
✓ HC GMP (1)
Quick Facts: Societal CDMO Gainesville (Bend Bioscience)
- Signal Score
- Profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed. How scoring works
- Headquarters
- United States
- Website
- https://bendbioscience.com/
- Modalities
- Oral Solid Dose
- Active Programs
- No ClinicalTrials.gov matches confirmed
- Data Sources
- FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring
About Societal CDMO Gainesville (Bend Bioscience)
Societal CDMO Gainesville (Bend Bioscience) is a contract development and manufacturing organization (CDMO). Capabilities: Oral Solid Dose. 2 manufacturing sites registered with the U.S. FDA and Health Canada: Gainesville, GA and Clearwater, FL (formerly CoreRx). Website: https://bendbioscience.com/
Signal Score
Profiled, not yet scored.
Scores are published after regulatory evidence is attached and reviewed.
How scoring works
Societal CDMO Gainesville (Bend Bioscience) FDA Inspection History
2026-02
2025-03
2024-11
NAI
VAI
OAI
| Date | Site | Type | Observations | Classification |
|---|---|---|---|---|
| 2026-02-26 |
CoreRX Inc.
Clearwater, Florida
Company-level
|
Drug Quality Assurance | Yes | Voluntary Action Indicated (VAI) |
| 2025-03-20 |
CoreRX Inc.
Clearwater, Florida
Company-level
|
Vaccines and Allergenic Products | Yes | Voluntary Action Indicated (VAI) |
| 2024-11-19 |
Societal CDMO Gainesville, LLC
Gainesville, Georgia
Company-level
|
Drug Quality Assurance | Yes | Voluntary Action Indicated (VAI) |
Source: FDA Data Dashboard · Retrieved Oct 31, 2026
Societal CDMO Gainesville (Bend Bioscience) FDA 483 Findings 14 observations · 2024-11-19 → 2026-02-26 ?
By subsystem
By severity
- 5 — Critical: 2
- 3 — Moderate: 2
- 2 — Minor: 10
- Repeat observations: 1
Most severe findings
-
Computer control of master formula records
"Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel."
-
Computer control of master formula records
"Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel."
-
Component written specification
"Component testing is deficient in that each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality."
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 10 articles
Company announcements, not verified evidence. They do not change any score.
Societal CDMO Enters Into Definitive Agreement to be Acquired by CoreRx, Inc. - GlobeNewswire
CoreRx, Societal CDMO, and Bend Bioscience Unite Under the Bend Bioscience Brand to Provide World Class CDMO offering - PR Newswire
GHCC: Bend Bioscience expanding - 97.5 Glory FM
Meribel Pharma Solutions launches to take pharma services to new heights - Pharmafile
NovaQuest Private Equity Announces Investment In Bend Bioscience to Broaden CoreRx Offering - PR Newswire
Bend Bioscience’s Expanded Vision for Complex Drug Delivery - Contract Pharma
Owen Murray Tapped as CEO of Combined Bend Bioscience, CoreRx and Societal Entities - Contract Pharma
Bend Bioscience adds commercial spray drying facility to Georgia site - Pharmafile
Bioscience Company Announces Plans for Bend-Based Lab - oregonbusiness.com
Modified Release Dosage Forms: Giving New Life to Drugs - Contract Pharma
Frequently Asked Questions About Societal CDMO Gainesville (Bend Bioscience)
How many FDA inspections does Societal CDMO Gainesville (Bend Bioscience) have on record?
CDMO Signal tracks 3 FDA inspections for Societal CDMO Gainesville (Bend Bioscience), sourced from the FDA inspection database. See the full inspection history above.
Has Societal CDMO Gainesville (Bend Bioscience) received an FDA warning letter?
CDMO Signal has no FDA warning letters on record for Societal CDMO Gainesville (Bend Bioscience).
Does Societal CDMO Gainesville (Bend Bioscience) have a CDMO Signal Score?
Not yet. Societal CDMO Gainesville (Bend Bioscience) is profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed.
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