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The US Food and Drug Administration that inspected Dr Reddy’s Laboratories active pharmaceutical ingredients (API) unit at Miryalaguda in Telangana in March this year, has provided an ‘establishment inspection report’ to it.
The company, on February 21, informed that the FDA had issued form 483 with three observations.
It has said in a filing that “In that regard, we would now like to inform you that we have received an establishment inspection report (EIR) from the USFDA today as closure of audit for the above referred facility.”
