Swiss-American CDMO

United States
Semi-solids & Liquids Packaging & Labeling
Program data pending ClinicalTrials.gov matching
Profiled
Not yet scored
✓ FDA Inspections (1) ○ Clinical Trials ○ SEC Filings ○ Press ○ EMA GMP ○ MHRA GMP ✓ HC GMP (7)

Quick Facts: Swiss-American CDMO

Signal Score
Profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed. How scoring works
Headquarters
United States
Website
Modalities
Semi-solids & Liquids, Packaging & Labeling
Active Programs
No ClinicalTrials.gov matches confirmed
Data Sources
FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring

About Swiss-American CDMO

Swiss-American CDMO is a contract development and manufacturing organization (CDMO). Capabilities: Semi-solids & Liquids, Packaging & Labeling. 1 manufacturing site registered with the U.S. FDA and Health Canada. Website: https://www.sacdmo.com/

Signal Score

Profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed. How scoring works

Swiss-American CDMO FDA Inspection History

2022-03
NAI VAI OAI
Date Site Type Observations Classification
2022-03-31
Swiss American CDMO, LLC
Carrollton, Texas Company-level
Drug Quality Assurance Yes Voluntary Action Indicated (VAI)
Source: FDA Data Dashboard · Retrieved Oct 31, 2026

Swiss-American CDMO FDA 483 Findings 14 observations · 2022-03-31 → 2024-12-16 ?

By subsystem

  • Other 4 (28.6%)
  • Documentation & Records 4 (28.6%)
  • Process Validation 2 (14.3%)
  • CAPA 2 (14.3%)
  • Personnel & Training 1 (7.1%)
  • Equipment & Facilities 1 (7.1%)

By severity

  • 4 — Serious: 2
  • 3 — Moderate: 2
  • 2 — Minor: 10
  • Repeat observations: 1

Most severe findings

  • Serious (4) Process Validation 2024-12-16 21 CFR 820.75(a)
    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."

  • Serious (4) Process Validation 2022-12-19 21 CFR 820.75(a)
    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."

  • Moderate (3) CAPA 2022-12-19 21 CFR 820.100(a)
    Lack of or inadequate procedures

    "Procedures for corrective and preventive action 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 Swiss-American CDMO

How many FDA inspections does Swiss-American CDMO have on record?
CDMO Signal tracks 1 FDA inspection for Swiss-American CDMO, sourced from the FDA inspection database. See the full inspection history above.
Has Swiss-American CDMO received an FDA warning letter?
CDMO Signal has no FDA warning letters on record for Swiss-American CDMO.
Does Swiss-American CDMO have a CDMO Signal Score?
Not yet. Swiss-American CDMO is profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed.
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