A formulations manufacturing facility of Dr. Reddy’s Laboratories in Hyderabad, which was issued a Form 483 with ten observations in October by the United States Food and Drug Administration, has obtained an institution inspection report (EIR) with the regulator classifying the inspection as voluntary motion indicated (VAI).
“We wish to inform that the company has received the establishment inspection report. The U.S. FDA has classified the inspection as VAI and concluded the inspection is closed,” the drugmaker stated in a submitting on Saturday.
In October, the corporate stated the U.S. FDA, following the inspection, had issued a Form 483 with ten observations, which it will deal with inside the stipulated timeline.
