Drug major Dr Reddy's Laboratories said it has received establishment inspection report (EIR) from the US Food and Drug Administration (USFDA) for Srikakulum Plant (SEZ) Unit I, Andhra Pradesh. The EIR indicates closure of the audit while the inspection classification of this facility is determined as No Action Initiated (NAI).

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"Further to our intimation dated February 14, 2020 with regard to the audit of our Formulations Srikakulum Plant (SEZ) Unit I, Andhra Pradesh, we would like to inform that we have received the Establishment Inspection Report from USFDA, for the above-referred facility," Dr Reddy's Laboratories said in a regulatory filing.

The drugmaker had informed the exchanges on February 14 this year that the said unit received zero observations from the USFDA audit.​

The USFDA had issued a warning letter to the facility in November, 2015, after inspecting it in 2014.

First Published:May 13, 2020 12:53 PM IST