Alkem Laboratories Ltd. said the U.S. Food and Drug Administration recorded 13 violations at its manufacturing facilities in India and the U.S.
The regulator issued a Form 483 following an inspection at the company's plants in Daman, India, and St. Louis.
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.
The company has already submitted a corrective and preventive action plan to the FDA for its U.S.-based facility.
Alkem plans to submit a response for the Indian facility in the future.