80%Confidence
0Views
FDASource
2026-03-05Date
Summary
Fresenius Kabi's sterility assurance failure for thiamine compounds raises concerns about their compounding facility's quality systems. This could impact their contract manufacturing business and lead to increased regulatory scrutiny.
Actionable: Review Fresenius Kabi's compounding business segment for potential revenue impacts from this regulatory action.
AI Confidence: 80%
Data Points
firmFresenius Kabi Compounding, LLC
classificationClass II
statusOngoing
distributionUS Nationwide.
productthiamine HCl, 500 mg, 500 mg added to 100 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-0
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