Alembic Pharmaceuticals on Monday said the U.S. Food and Drug Administration (U.S. FDA) has issued a warning letter to the clinical Investigator associated with a bioequivalence study conducted at the company’s bioequivalence facility in Vadodara.
The warning letter pertains to observation regarding informed consent form (ICF) in relation to a bioequivalence study. The observations do not relate to data integrity. Based on the company’s preliminary assessment, the warning letter does not impose any restriction on the operations of the bioequivalence facility. It is coordinating with the Clinical Investigator for submission of an appropriate response to the U.S. FDA within the stipulated timeline, Alembic said in a filing.
The U.S. FDA had inspected the facility from March 3-7, 2025 and issued a Form 483 with one observation, which the company said was a procedural observation.
Published – July 13, 2026 10:53 pm IST