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Importance
52
Trust
89
Urgency
30
REGULATORY · PRIMARY SOURCE
Pharmathen International S.A. - 723680 - 05/27/2026
Analysis
FDA found serious sterility problems at a Greek drug factory. Products made there for the US market may be at risk of contamination.
- FDA inspected Pharmathen International S.A. in Greece, Nov 10–21, 2025
- Warning letter cites sterile manufacturing violations including gram-negative microbes in ISO 5 air samples
- Firm's Dec 15, 2025 response deemed inadequate by FDA
FDA Drug Approvals & Databases4d
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