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The FDA concluded that the company's manufacturing systems, laboratory controls, and quality oversight failed to comply with Current Good Manufacturing Practice (CGMP) requirements, ultimately classifying products manufactured at the facility as adulterated under the Federal Food, Drug, and Cosmetic Act—not because contamination was confirmed, but because the quality systems could no longer be relied upon
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As detailed below, further time-kill assays confirm that the observed membrane damage accompanies loss of cell viability
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