Dr. Reddy’s Laboratories’ active pharmaceutical ingredient (API) manufacturing plant-5 in Miryalaguda of Nalgonda District in Telangana has received an Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (USFDA).
“We have received an EIR from USFDA for the facility, indicating closure of the audit and the inspection classification of this facility is determined as voluntary action indicated (VAI), the pharma major said in a filing with the stock exchanges on Thursday.
The USFDA had completed audit of the API manufacturing plant last month and issued a Form 483 with three observations. “We will address them comprehensively within the stipulated timeline,” the company had said in a communication on March 5.
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