Avara Liscate Pharmaceutical Services
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
- https://www.avara.com/
- 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
Avara Liscate Pharmaceutical Services FDA Inspection History
| 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) |
Avara Liscate Pharmaceutical Services FDA 483 Findings 3 observations · 2022-12-06 → 2022-12-06 ?
By subsystem
By severity
- 3 — Moderate: 1
- 2 — Minor: 2
- Repeat observations: 0
Most severe findings
-
Written record of investigation incomplete
"Written records of investigations into unexplained discrepancies do not include the conclusions and follow-up."
-
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."
-
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
| 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 |