New Delhi: Sun Pharmaceutical Industries on Wednesday said it has received establishment inspection report (EIR) from the US health regulator for its Dadra facility.
The company said it had earlier indicated in the regulatory filings to the bourses that it was in the process of responding to the Form-483 observation letter issued by the USFDA after the inspection of its Dadra facility.
“We are now pleased to inform you that the above-referred inspection is closed,” Sun Pharma said in a BSE filing.
The company has received “a communication from the United States Food and Drug Administration (USFDA) releasing a copy of the EIR in respect of the above inspection based upon responses to the said observation letter”, it added.
The Mumbai based pharma major, however, did not share the details of the EIR.
In April, it had received 11 observations from the USFDA after the inspection of its Dadra facility.
As per USFDA, after the completion of an inspection of a facility, an EIR is issued to a company detailing inspection findings.