U.S. FDA Maintains OAI Status On Dr. Reddy’s Srikakulam Plant
USFDA has maintained OAI status at Srikakulam API manufacturing plant, says Dr. Reddy’s.
Pharmaceutical major Dr. Reddys Laboratories Ltd. said on Sunday that 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 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, the company 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.
Dr Reddy’s had said that it was addressing those issues.
Also Read: Dr. Reddy’s Q3 Profit Misses Estimates, Margins Fall