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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

Press Trust of India  |  New Delhi 

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

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,

The company, without mentioning the contents of the EIR, said the has maintained (Official Action Indicated) status at its API manufacturing plant in

The US 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 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 issues an 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 and issuance of two observations by the US

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

First Published: Sun, February 25 2018. 21:31 IST
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