483
Emergent Biodefense Operations Lansing LLCEmergent Biodefense Operations Lansing LLC – FDA 483, Jun 30, 2026
Record Details
Emergent Biodefense Operations Lansing LLC in Lansing, MI, was inspected regarding its licensed biologics manufacturing. The inspection revealed significant failures in establishing adequate written procedures for production and process controls, leading to recurring quality issues and the rejection of numerous CYFENDUS drug product lots. These issues indicate a severe lack of control over product quality, purity, and identity.
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ID · 676663f4-639c-418a-b299-2a0d3caab5af
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