Divis Lab Vizag unit gets USFDA EIR with 6 observations

Published On 2017-11-20 05:15 GMT   |   Update On 2021-08-18 06:47 GMT

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.

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Article Source : PTI

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