When the Consent Form Is the Catastrophe: What Alembic's FDA Warning Letter Means for Your Site

Alembic Pharmaceuticals received an FDA warning letter for obtaining informed consent after study procedures had begun at its bioequivalence facility in India. The deficiency, exposed during a BIMO inspection in March 2025, raises questions about data integrity in any ANDA submissions relying on that site's bioequivalence data.

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