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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

medicine, pharma, drugs

Press Trust of India New Delhi
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.

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First Published: Nov 18 2017 | 2:16 PM IST

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