Divis Lab Vizag unit gets USFDA EIR with 6 observations
New Delhi: Drug firm Divis Laboratories on Saturday said it has received an establishment inspection report (EIR) from the US health regulator for its unit in Visakhapatnam.
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.