Business Standard

Dr Reddy's gets EIR, says USFDA maintained OAI status for Srikakulam plant

An OAI status is equivalent to finding of objectionable conditions at the audit site and also an indicator of regulatory and/or administrative sanctions by FDA

Dr Reddy's buys 8 drugs from Teva, Allergan in $350 mn deal

Press Trust of India New Delhi
Pharma major Dr Reddy's on Sunday said it has received the establishment inspection report (EIR) from the US Food and Drug Administration for its formulations facility in Srikakulam, Andhra Pradesh.

The company, 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 asked the company for more details, it said.

"FDA has asked us for more details. We are providing those details and continuing to engage with FDA for resolution of pending issues," Dr Reddy's said in a regulatory filing.

An OAI status is equivalent to finding of objectionable conditions at the audit site and also an indicator 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, the company had informed about the completion of the audit at its API manufacturing plant in Andhra Pradesh and issuance of two observations by the US drug regulator.

Dr Reddy's had said that it was addressing those issues.

Don't miss the most important news and views of the day. Get them on our Telegram channel

First Published: Feb 25 2018 | 9:31 PM IST

Explore News