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Divis Lab Vizag unit gets USFDA EIR with 6 observations


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.



Source: PTI
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