Dr Reddy’s gets establishment inspection report from USFDA for Srikakulam plant
Dr Reddy’s has received the establishment inspection report (EIR) from the US Food and Drug Administration (US FDA) for its formulations facility located in Srikakulam, Andhra Pradesh.
Hyderabad: Dr Reddy’s has received the establishment inspection report (EIR) from the US Food and Drug Administration (US FDA) for its formulations facility located in Srikakulam, Andhra Pradesh.
The drug major on Sunday, without mentioning the contents of the EIR, said the USFDA has maintained OAI (Official Action Indicated) status at its API manufacturing plant in Srikakulam. The US drug regulator has sought more details.
Dr Reddy's in a communique to BSE said: “FDA has asked us for more details. We are providing those details and continuing to engage with FDA for resolution of pending issues.”
An OAI status is equivalent to finding of objectionable conditions at the audit site and also an indicative of regulatory and/or administrative sanctions by FDA.
The USFDA issues an EIR to an establishment that is the subject of an FDA or FDA-contracted inspection when the agency decides to close the inspection.
In April 2017, Dr Reddy’s had informed about completion of the audit at its API manufacturing plant in Andhra Pradesh and issuance of two observations by the US drug regulator. The drug major further added that it’s addressing those issues.