Avara Liscate Pharmaceutical Services

Italy
Oral Solid Dose Sterile Fill-Finish
Program data pending ClinicalTrials.gov matching
Profiled
Not yet scored
✓ FDA Inspections (3) ○ Clinical Trials ○ SEC Filings ○ Press ✓ EMA GMP (3) ○ MHRA GMP ✓ HC GMP (2)

Quick Facts: Avara Liscate Pharmaceutical Services

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

About Avara Liscate Pharmaceutical Services

Avara Liscate Pharmaceutical Services is a contract development and manufacturing organization (CDMO). Capabilities: Oral Solid Dose, Sterile Fill-Finish. 1 manufacturing site registered with the U.S. FDA and Health Canada. Website: https://www.avara.com/

Signal Score

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

Avara Liscate Pharmaceutical Services FDA Inspection History

2026-02
2023-06
2022-12
NAI VAI OAI
Date Site Type Observations Classification
2026-02-20
Avara Liscate Pharmaceutical Services SPA
Liscate Company-level
Drug Quality Assurance No Voluntary Action Indicated (VAI)
2023-06-09
Avara Liscate Pharmaceutical Services SPA
Liscate Company-level
Drug Quality Assurance No Voluntary Action Indicated (VAI)
2022-12-06
Avara Liscate Pharmaceutical Services SPA
Liscate Company-level
Drug Quality Assurance Yes Voluntary Action Indicated (VAI)
Source: FDA Data Dashboard · Retrieved Oct 31, 2026

Avara Liscate Pharmaceutical Services FDA 483 Findings 3 observations · 2022-12-06 → 2022-12-06 ?

By subsystem

  • Equipment & Facilities 1 (33.3%)
  • Documentation & Records 1 (33.3%)
  • CAPA 1 (33.3%)

By severity

  • 3 — Moderate: 1
  • 2 — Minor: 2
  • Repeat observations: 0

Most severe findings

  • Moderate (3) CAPA 2022-12-06 21 CFR 211.192
    Written record of investigation incomplete

    "Written records of investigations into unexplained discrepancies do not include the conclusions and follow-up."

  • Minor (2) Equipment & Facilities 2022-12-06 21 CFR 211.46(b)
    Equipment for Environmental Control

    "Equipment for adequate control over micro-organisms is not provided when appropriate for the manufacture, processing, packing or holding of a drug product."

  • Minor (2) Documentation & Records 2022-12-06 21 CFR 211.188(b)
    Batch production and Batch Control Record Requirements

    "The batch production and control records are deficient in that they do not include documentation of the accomplishment of each significant step in manufacturing."

Avara Liscate Pharmaceutical Services EMA GMP Compliance 3 certificates

2026-02
2016-02
2016-02
Compliant Non-Compliant
Certificate Site Country Inspection Date Status
IT/105/H/2026 Avara Liscate Pharmaceutical Services S.p.A. Italy 2026-02-20 COMPLIANT
IT-API/165/H/2019 AVARA LISCATE PHARMACEUTICAL SERVICES S.p.A. Italy 2016-02-02 COMPLIANT
IT-API/218/H/2022 Avara Liscate Pharmaceutical Services S.p.A. Italy 2016-02-02 COMPLIANT
Source: EMA EudraGMDP · Retrieved Oct 31, 2026

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 Avara Liscate Pharmaceutical Services

How many FDA inspections does Avara Liscate Pharmaceutical Services have on record?
CDMO Signal tracks 3 FDA inspections for Avara Liscate Pharmaceutical Services, sourced from the FDA inspection database. See the full inspection history above.
Has Avara Liscate Pharmaceutical Services received an FDA warning letter?
CDMO Signal has no FDA warning letters on record for Avara Liscate Pharmaceutical Services.
Does Avara Liscate Pharmaceutical Services hold EMA or MHRA GMP certificates?
CDMO Signal tracks 3 EMA GMP certificates for Avara Liscate Pharmaceutical Services.
Does Avara Liscate Pharmaceutical Services have a CDMO Signal Score?
Not yet. Avara Liscate Pharmaceutical Services is profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed.
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