Alembic Pharmaceuticals Ltd. said the U.S. Food and Drug Administration observed three violations at its formulation facility in India.
The U.S. regulator issued a Form 483 following an audit at the company's plant, located in India's Gujarat state.
A form 483 is issued when investigators observe any conditions or practices that may have violated the Food Drug and Cosmetic Act and could later pose health hazards to consumers.
Vadodara, Gujarat-based Alembic said none of the observations were related to data integrity or repetitive in nature.
The company said it will submit a response to the U.S. FDA shortly.