Generic drugmaker Dr. Reddy’s Laboratories has received establishment inspection report (EIR) for its Srikakulam formulations manufacturing facility from the U.S. Food and Drug Administration (U.S. FDA) with a voluntary action indicated (VAI) classification.
Following a good manufacturing practice (GMP) and a pre-approval inspection (PAI) in July, the facility (FTO 11) received seven observations from the U.S. FDA. Citing its July 18 intimation to the stock exchanges, made in the wake of the observations, Dr. Reddy’s on Tuesday, in a filing, said the company received the EIR on October 20. “The USFDA has classified the inspection outcome as VAI and concluded that the inspection is officially closed under 21 CFR 20.64(d)(3),” it said.
One of the three classifications, the U.S. FDA issues to determine outcome of its inspection, VAI means objectionable conditions or practices were found, but the regulator is not prepared to take or recommend any administrative or regulatory action. No action indicated (NAI) is another classification, which means no objectionable conditions or practices were found during the inspection, while the third category of classificaton is official action indicated or OAI that means regulatory and/or administrative actions are recommended.
Published – October 21, 2025 07:53 pm IST
