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An active pharmaceutical ingredients (API) manufacturing facility of Dr. Reddy’s Laboratories in Hyderabad inspected last year by the United States Food and Drug Administration (U.S. FDA) has since been classified as Voluntary Action Indicated (VAI) by the agency.
“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) said in an update to the stock exchanges on the inspection of the API manufacturing facility (CTO-2) in Bollaram, Hyderabad.
The U.S. FDA had conducted the GMP inspection from November 13-19 and issued a Form 483 with seven observations to the facility.
Published – February 25, 2025 05:56 pm IST
