FDA’s DSCSA Enforcement Escalates: Lessons from the Pure Indulgence Warning Letter



When the Food and Drug Administration issued its first Drug Supply Chain Security Act warning letter to a dispenser in April 2026, it marked a turning point in pharmaceutical compliance enforcement. The case of Pure Indulgence Aesthetics demonstrates that DSCSA requirements are no longer theoretical obligations—they’re actively enforced mandates with serious financial and operational consequences.

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