The U.S. Food and Drug Administration (FDA) has raised concerns over manufacturing controls at a Teva Pharmaceutical Industries plant in China, Israel's biggest company said in a regulatory filing on Thursday.
Teva said the FDA's warning letter, which it received on April 10, stemmed from a regulatory inspection of the plant in September.
Teva said on Thursday it was in the process of addressing the agency's concerns and will respond to the letter by May 1.
Teva's NYSE-listed shares were marginally down at $31.97 in early morning trading.
(Reporting by Natalie Grover in Bengaluru; Editing by Sriraj Kalluvila)