U.S. FDA issues two observations to Dr. Reddy’s API plant in Telangana 

The United States Food and Drug Administration (U.S. FDA) has issued a Form 483 with two observations to generic drugmaker Dr. Reddy’s Laboratories’ active pharmaceutical ingredients (API) manufacturing facility in Miryalaguda, Telangana.

The U.S. FDA conducted a Good Manufacturing Practices (GMP) inspection of the API manufacturing facility (CTO-5) in Miryalaguda from May 19-24. “We have been issued a Form 483 with 2 observations, which we will address within the stipulated timeline,” the company said in a filing on Saturday.