BSP Pharmaceuticals

Latina, Italy
Biologics mRNA
Program data pending ClinicalTrials.gov matching · Last scored 2026-04-29
53.9
Signal Score
✓ FDA Inspections (7) ○ Clinical Trials ○ SEC Filings ○ Press ✓ EMA GMP (12) ○ MHRA GMP

Quick Facts: BSP Pharmaceuticals

Signal Score
53.9/100 (as of 2026-04-29)
Quality Compliance
48.0/100 — OAI classification at Levittown (2025-10-15) — CRITICAL
Headquarters
Latina, Italy
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 48.0
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 Certificates12 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

BSP Pharmaceuticals 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 Jul 04, 2026

BSP Pharmaceuticals FDA 483 Findings 18 observations · 2025-08-01 → 2025-11-18 ?

By subsystem

  • Documentation & Records 5 (27.8%)
  • CAPA 5 (27.8%)
  • Other 4 (22.2%)
  • Equipment & Facilities 2 (11.1%)
  • Laboratory Controls 1 (5.6%)
  • Data Integrity 1 (5.6%)

By severity

  • 5 — Critical: 1
  • 3 — Moderate: 6
  • 2 — Minor: 11
  • Repeat observations: 0

Most severe findings

  • Critical (5) Data Integrity 2025-10-15 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 2025-11-18 21 CFR 211.192
    Investigations of discrepancies, failures

    "There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed."

  • Moderate (3) CAPA 2025-10-15 21 CFR 211.192
    Investigations of discrepancies, failures

    "There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed."

About this data →

BSP Pharmaceuticals EMA GMP Compliance 12 certificates

2025-02
2024-10
2024-10
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/45/H/2026 Bsp Pharmaceuticals S.p.A. Italy 2024-10-11 COMPLIANT
IT-API/75/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 Jul 04, 2026

Frequently Asked Questions About BSP Pharmaceuticals

How many FDA inspections does BSP Pharmaceuticals have on record?
CDMO Signal tracks 7 FDA inspections for BSP Pharmaceuticals, sourced from the FDA inspection database. See the full inspection history above.
Has BSP Pharmaceuticals received an FDA warning letter?
CDMO Signal has no FDA warning letters on record for BSP Pharmaceuticals.
Does BSP Pharmaceuticals hold EMA or MHRA GMP certificates?
CDMO Signal tracks 12 EMA GMP certificates for BSP Pharmaceuticals.
What is BSP Pharmaceuticals's CDMO Signal Score?
BSP Pharmaceuticals has a Signal Score of 54/100, based on quality, operations, financial stability, and capacity data.
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