An energetic pharmaceutical components (API) manufacturing facility of Dr. Reddy’s Laboratories in Hyderabad inspected final yr by the United States Food and Drug Administration (U.S. FDA) has since been categorized as Voluntary Action Indicated (VAI) by the company.
“The U.S. FDA has classified the inspection as VAI and concluded that the inspection is closed…,” the generic drugmaker on Tuesday (February 25, 2025) mentioned in an replace to the inventory exchanges on the inspection of the API manufacturing facility (CTO-2) in Bollaram, Hyderabad.
The U.S. FDA had performed the GMP inspection from November 13-19 and issued a Form 483 with seven observations to the ability.
Published – February 25, 2025 05:56 pm IST