Plastikon Healthcare

United States
Hybrid — also manufactures internal programs
Sterile Fill-Finish Semi-solids & Liquids
Program data pending ClinicalTrials.gov matching
Profiled
Not yet scored
✓ FDA Inspections (2) ○ Clinical Trials ○ SEC Filings ○ Press ○ EMA GMP ○ MHRA GMP

Quick Facts: Plastikon Healthcare

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

About Plastikon Healthcare

Plastikon Healthcare makes its own pharmaceutical products and also offers contract development and manufacturing services. Capabilities: Sterile Fill-Finish, Semi-solids & Liquids. 1 manufacturing site registered with the U.S. FDA. Website: https://www.plastikon.com/

Signal Score

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

Plastikon Healthcare FDA Inspection History

2024-04
2021-11
NAI VAI OAI
Date Site Type Observations Classification
2024-04-30
Plastikon Healthcare LLC
Lawrence, Kansas Company-level
Drug Quality Assurance No No Action Indicated (NAI)
2021-11-04
Plastikon Healthcare LLC
Lawrence, Kansas Company-level
Drug Quality Assurance Yes Official Action Indicated (OAI)
Source: FDA Data Dashboard · Retrieved Oct 31, 2026

Plastikon Healthcare FDA 483 Findings 11 observations · 2021-11-04 → 2021-11-04 ?

By subsystem

  • Documentation & Records 3 (27.3%)
  • Other 2 (18.2%)
  • Laboratory Controls 2 (18.2%)
  • CAPA 2 (18.2%)
  • Personnel & Training 1 (9.1%)
  • Data Integrity 1 (9.1%)

By severity

  • 5 — Critical: 1
  • 3 — Moderate: 4
  • 2 — Minor: 6
  • Repeat observations: 0

Most severe findings

  • Critical (5) Data Integrity 2021-11-04 21 CFR 211.68(b)
    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."

  • Moderate (3) CAPA 2021-11-04 21 CFR 211.192
    Investigations of discrepancies, failures

    "There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed."

  • Moderate (3) Laboratory Controls 2021-11-04 21 CFR 211.160(b)
    Scientifically sound laboratory controls

    "Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards and test procedures designed to assure that components and drug products conform to appropriate standards of identity, strength, quality and purity."

About this data →

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 Plastikon Healthcare

How many FDA inspections does Plastikon Healthcare have on record?
CDMO Signal tracks 2 FDA inspections for Plastikon Healthcare, sourced from the FDA inspection database. See the full inspection history above.
Has Plastikon Healthcare received an FDA warning letter?
CDMO Signal has no FDA warning letters on record for Plastikon Healthcare.
Does Plastikon Healthcare have a CDMO Signal Score?
Not yet. Plastikon Healthcare is profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed.
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