Divi's Laboratories unit-II at Visakhapatnam was inspected by the USFDA in September 2017 wherein a form-483 was issued with six observations.
"We have now received an Establishment Inspection Report (EIR) from US-FDA for our Unit-II, as the closure of audit by FDA," the company said in a BSE filing.
The USFDA releases a copy of the EIR to the establishment that was the subject of an FDA inspection when the agency determines the inspection to be closed.