Formulated Solutions
Largo, Florida, United States
Program data pending ClinicalTrials.gov matching
Profiled
Not yet scored
✓ FDA Inspections (2)
○ Clinical Trials
○ SEC Filings
✓ Press (10)
○ EMA GMP
○ MHRA GMP
Quick Facts: Formulated Solutions
- Signal Score
- Profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed. How scoring works
- Headquarters
- Largo, Florida, United States
- Website
- https://www.formulatedsolutions.com/
- Modalities
- Topicals, Inhalation & Nasal, Finished Dosage Forms, Oral Liquids, Semi-solids & Liquids
- Active Programs
- No ClinicalTrials.gov matches confirmed
- Data Sources
- FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring
About Formulated Solutions
Formulated Solutions is a contract development and manufacturing organization (CDMO). Capabilities: Topicals, Inhalation & Nasal, Finished Dosage Forms, Oral Liquids, Semi-solids & Liquids. 2 manufacturing sites registered with the U.S. FDA and Health Canada. Website: https://www.formulatedsolutions.com/
Signal Score
Profiled, not yet scored.
Scores are published after regulatory evidence is attached and reviewed.
How scoring works
Formulated Solutions FDA Inspection History
2025-04
2024-04
NAI
VAI
OAI
| Date | Site | Type | Observations | Classification |
|---|---|---|---|---|
| 2025-04-04 |
Formulated Solutions, LLC
Largo, Florida
Company-level
|
Drug Quality Assurance | Yes | Voluntary Action Indicated (VAI) |
| 2024-04-12 |
Formulated Solutions Cleveland LLC
Cleveland, Tennessee
Company-level
|
Drug Quality Assurance | Yes | Voluntary Action Indicated (VAI) |
Source: FDA Data Dashboard · Retrieved Nov 01, 2026
Formulated Solutions FDA 483 Findings 3 observations · 2024-04-12 → 2025-04-04 ?
By subsystem
By severity
- 3 — Moderate: 1
- 2 — Minor: 2
- Repeat observations: 0
Most severe findings
-
Scientifically sound laboratory controls
"Laboratory controls do not include the establishment of scientifically sound and appropriate specifications designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity."
-
Procedures not in writing, fully followed
"The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed."
-
Cleaning / Sanitizing / Maintenance
"Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the 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 yet. We haven't found a public jobs feed for this company.
Source:
public careers pages
· Checked Oct 31, 2026
Company Signals 10 articles
Company announcements, not verified evidence. They do not change any score.
North America Topical Drugs CDMO Market Size Report 2030 - Grand View Research
Formulated Solutions Names 2 New Vice Presidents - Healthcare Packaging
Formulated Solutions inks deal to buy former Merck, Bayer manufacturing facility - Fierce Pharma
AustinPx Names Derek Hennecke and Marshall Crew to its Board of Directors - Business Wire
Formulated Solutions Adds Third GMP Aerosol Production Line - Contract Pharma
Florida CDMO New Vision Pharmaceuticals shutters plant, lays off 88 workers - Fierce Pharma
Formulated Solutions - Manufacturing Today
Formulated Solutions Signs Agreement to Acquire 455,000ft2 US FDA Approved Drug Production Site - PR Newswire
Fujifilm Irvine Scientific, Formulated Solutions each lay off 50-plus staffers, filings show - Fierce Pharma
Expert Statement: Victor Swint, Formulated Solutions - CHEManager
Frequently Asked Questions About Formulated Solutions
How many FDA inspections does Formulated Solutions have on record?
CDMO Signal tracks 2 FDA inspections for Formulated Solutions, sourced from the FDA inspection database. See the full inspection history above.
Has Formulated Solutions received an FDA warning letter?
CDMO Signal has no FDA warning letters on record for Formulated Solutions.
Does Formulated Solutions have a CDMO Signal Score?
Not yet. Formulated Solutions is profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed.
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