Dr Reddys Labs has received the Establishment Inspection Report (EIR) from the US Food and Drug Administration (USFDA) for the formulations manufacturing facility in Srikakulam, Andhra Pradesh.
USFDA had conducted an inspection on 7th July 2022 at formulations manufacturing facility (FTO 11) in Srikakulam, Andhra Pradesh.
EIR is the name given by the US Food and Drug Administration (US FDA) for an entire narration of what the FDA investigator / inspector did during the time spent at the establishment (facility), from the stage of introductions till the handover of the inspectional observations.
FDA has concluded that the inspection is "closed" under 21 C.F.R.20.64(d)(3) which means the consideration of regulatory enforcement action based upon a particular record shall be deemed to be closed.
