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US Food and Drug Administration has granted the Establishment Inspection Report (EIR) to the pharmaceutical company, Dr Reddy’s, for its formulations facility in Srikakulam, Andhra Pradesh.
The company had informed in April 2017 about the completion of its audit for API manufacturing plant that is located in Andhra Pradesh. Two observations were also issued by the US drug regulator of which the pharma major had mentioned. Though they have not mentioned the contents of EIR, the company has stated that USFDA has maintained the status of Official Action Indicated (OAI) for their Srikakulam plant.
Dr Reddy’s was quoted saying in a regulatory filing that “FDA has asked us for more details. We are providing those details and continuing to engage with FDA for resolution of pending issues.”
The OAI status is considered to be equal finding conditions that are objectionable at the audit site. It is also an indication of sanctions by FDA that are regulatory and/or administrative.
