483
Solventum US LLCSolventum US LLC – FDA 483, Sep 6, 2024
Record Details
Solventum US LLC in Columbia, MO, a manufacturer of drug products, was cited with two observations during an FDA inspection. The firm's stability program for drug products lacked reliable test methods for degradation impurities. Additionally, the inspection found inadequate controls over computer systems, with multiple production personnel sharing a single login account for critical equipment.
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ID · d6db10f1-99fd-4747-9d6c-5b05c7f367a4
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