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