Bußgelder bei Rückrufversäumnis
Definition
Failing to undertake a required product recall in pharmaceuticals results in penalties up to €100,000, plus potential criminal liability under Arzneimittelgesetz for distributing unsafe drugs.
Key Findings
- Financial Impact: €100,000 penalty per recall failure incident
- Frequency: Per non-compliance event during recalls or field alerts
- Root Cause: Manual delays in defect detection, notification to authorities (BfArM, state agencies), or RAPEX reporting
Why This Matters
This pain point represents a significant opportunity for B2B solutions targeting Pharmaceutical Manufacturing.
Affected Stakeholders
Quality Managers, Compliance Officers, Manufacturing Directors
Deep Analysis (Premium)
Financial Impact
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Current Workarounds
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Methodology & Sources
Data collected via OSINT from regulatory filings, industry audits, and verified case studies.
Related Business Risks
Kosten durch Rückruf und Schadensersatz
Produktionsausfälle durch Serialisierungs-Engpässe
Verzögerungen und Bürokratie in der Änderungsfreigabe
Kosten der Abweichungsuntersuchung und CAPA
Bußgelder bei CAPA-Mängeln
Überstunden in CAPA-Prozessen
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