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 received an establishment inspection report (EIR) with the regulator classifying the inspection as voluntary action 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 said in a filing on Saturday.
In October, the company said the U.S. FDA, following the inspection, had issued a Form 483 with ten observations, which it would address within the stipulated timeline.
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