The United States Food and Drug Administration (USFDA) retains official action indicated (OAI) status of Aarti Drugs' Palghar unit, says Adhish Patil, Chief Financial Officer (CFO) of the company.
“We had import alert on this unit. We had inspection in second week of December in 2017. There were five observations, three of which we already gave the response in January and for two of them we have asked time till June, 2018,” he said.
“The OIA status means that as of now whatever the status quo was of the facility, it will remain that. So, we still cannot ship any goods to US with this status,” he added.
Patil also said that USFDA will come to inspect the Palghar plant and if satisfied will clear the facility.