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# No Informed Consent in Alembic Trial
- URL: https://www.fdaweb.com/no-informed-consent-in-alembic-trial/
- Published: 2026-07-21T12:00:00.000Z
- Updated: 2026-09-14T13:43:18.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161490

An FDA 3/3-3/7/2025 Bioresearch Monitoring inspection at the Alembic Research Center in Vadodara, Gujarat, India, found the facility did not obtain informed consent for a redacted *in vivo* bioequivalence study. A 7/10 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/alembic-pharmaceuticals-ltd-731020-07102026?ref=fdaweb.com) says it appears Alembic failed to adhere to the applicable statutory requirements in the Federal Food, Drug, and Cosmetic Act and applicable regulations.

FDA acknowledges the corrective and preventive actions the site has taken but says the firm’s response to the form FDA-483 was inadequate because it did not detail how the clinical investigator would personally ensure adequate compliance with the informed consent requirements.

Alembic was told to respond with a list of actions it has taken to prevent similar violations in the future.