BSP Pharmaceuticals
Latina, IT
Program data pending ClinicalTrials.gov matching
· Last scored 2026-04-29
52.9
Signal Score
✓ FDA Inspections (7)
○ Clinical Trials
○ SEC Filings
○ Press
✓ EMA GMP (10)
○ MHRA GMP
Quick Facts: BSP Pharmaceuticals
- Signal Score
- 52.9/100 (as of 2026-04-29)
- Quality Compliance
- 46.0/100 — OAI classification at Levittown (2025-10-15) — CRITICAL
- Headquarters
- Latina, IT
- Modalities
- Biologics, mRNA
- Active Programs
- No ClinicalTrials.gov matches confirmed
- Data Sources
- FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring
- Scored By
- CDMO Signal — independent CDMO intelligence platform
About BSP Pharmaceuticals
Pure-play CDMO.
Signal Score & Pillar Breakdown
Quality Compliance
46.0
OAI classification at Levittown (2025-10-15) — CRITICAL
Source: FDA Data Dashboard
OAI classification at Levittown (2025-10-15) — CRITICAL
FDA Inspections7 on record
Warning Letters0
Last InspectionVoluntary Action Indicated (VAI) (2025-11-18)
EMA GMP Certificates10 on record
OAI classification at Levittown (2025-10-15) — CRITICAL
Operations
—
No ClinicalTrials.gov facility matches confirmed for this manufacturer.
Programs
— no verified data
Sponsors— no verified data
ModalitiesBiologics, mRNA
No clinical trial matches found for this manufacturer
Operational score requires ClinicalTrials.gov data
Data sourced from ClinicalTrials.gov, FDA, SEC EDGAR, and verified press only. No unverified estimates shown.
Financial Stability
60.0
Private company
Financial assessment: 60.0/100
Source: SEC EDGAR, press monitoring
Profile-based financial assessment
SEC FilingsPrivate company
Private company
Financial assessment: 60.0/100
Capacity
58.0
1 manufacturing site: Latina, IT
Modalities: Biologics, mRNA
Capacity assessment: 58.0/100
Sites: Latina, IT
Source: SEC EDGAR, press monitoring, company profiles
1 manufacturing site
1 manufacturing site: Latina, IT
Modalities: Biologics, mRNA
Capacity assessment: 58.0/100
FDA Inspection History
2025-11
2025-10
2025-10
2025-09
2025-09
2025-08
2025-08
NAI
VAI
OAI
| Date | Site | Type | Observations | Classification |
|---|---|---|---|---|
| 2025-11-18 | Davie, Florida | Drug Quality Assurance | Yes | Voluntary Action Indicated (VAI) |
| 2025-10-15 | Levittown, Pennsylvania | Drug Quality Assurance | Yes | Official Action Indicated (OAI) |
| 2025-10-09 | Bridgewater, New Jersey | Bioresearch Monitoring | Yes | Voluntary Action Indicated (VAI) |
| 2025-09-12 | Chesterfield, Missouri | Bioresearch Monitoring | Yes | Voluntary Action Indicated (VAI) |
| 2025-09-11 | Ridgefield, Connecticut | Bioresearch Monitoring | Yes | Voluntary Action Indicated (VAI) |
| 2025-08-27 | Bunnell, Florida | Drug Quality Assurance | Yes | Voluntary Action Indicated (VAI) |
| 2025-08-01 | Des Moines, Iowa | Drug Quality Assurance | Yes | Voluntary Action Indicated (VAI) |
Source: FDA Data Dashboard · Retrieved May 20, 2026
FDA 483 Findings 18 observations · 2025-08-01 → 2025-11-18 ?
By subsystem
By severity
- 5 — Critical: 1
- 3 — Moderate: 6
- 2 — Minor: 11
- Repeat observations: 0
Most severe findings
-
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."
-
Investigations of discrepancies, failures
"There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed."
-
Investigations of discrepancies, failures
"There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed."
EMA GMP Compliance 10 certificates
2025-02
2024-10
2024-10
2024-10
2024-10
2022-05
2022-05
2021-11
2019-11
2019-11
Compliant
Non-Compliant
| Certificate | Site | Country | Inspection Date | Status |
|---|---|---|---|---|
| IT/42/H/2025 | Bsp Pharmaceuticals S.p.A. | Italy | 2025-02-21 | COMPLIANT |
| IT-API/12/H/2025 | Bsp Pharmaceuticals S.p.A. | Italy | 2024-10-11 | COMPLIANT |
| IT-API/25/H/2025 | Bsp Pharmaceuticals S.p.A. | Italy | 2024-10-11 | COMPLIANT |
| IT-API/83/H/2025 | Bsp Pharmaceuticals S.p.A. | Italy | 2024-10-11 | COMPLIANT |
| IT-API/10/H/2026 | Bsp Pharmaceuticals S.p.A. | Italy | 2024-10-11 | COMPLIANT |
| IT-API/7/H/2023 | Bsp Pharmaceuticals S.p.A. | Italy | 2022-05-27 | COMPLIANT |
| IT-API/72/H/2024 | Bsp Pharmaceuticals S.p.A. | Italy | 2022-05-27 | COMPLIANT |
| IT-API/79/H/2022 | Bsp Pharmaceuticals S.p.A. | Italy | 2021-11-12 | COMPLIANT |
| IT-API/107/H/2021 | BSP PHARMACEUTICALS S.P.A. | Italy | 2019-11-22 | COMPLIANT |
| IT-API/54/H/2021 | BSP PHARMACEUTICALS S.P.A. | Italy | 2019-11-22 | COMPLIANT |
Source: EMA EudraGMDP · Retrieved May 20, 2026
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