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Divi's Laboratories Vizag unit receives USFDA EIR with six observations

The USFDA releases a copy of the EIR to the establishment that was the subject of an FDA inspection

Press Trust of India  |  New Delhi 

medicine, pharma, drugs
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Drug firm Divi's 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.

First Published: Sat, November 18 2017. 14:16 IST
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