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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 Actnot because contamination was confirmed, but because the quality systems could no longer be relied upon

If a reformulated drug demonstrably improves patient outcomes reduced side effects, better adherence, fewer hospitalizations that clinical benefit justifies a price premium even in a Cost Plus environment

With the rise in several lawsuits, thorough medical records have become increasingly important in establishing liability