Dr. Reddy's Laboratories Ltd. said the U.S. Food and Drug Administration observed five violations at its plant in India.
The regulator issued a so-called form 483 following an audit at the company's active pharmaceutical ingredients manufacturing facility in the Medak district of the Telangana 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.
The Hyderabad, India-based generic-drug manufacturer said it will address the issues at the facility "comprehensively within the stipulated time."
