Stelis Biopharma’s facility receives EIR from USFDA

Establishment Inspection Report (EIR) from USFDA received for the drug-device combination to be commercialised from the company's flagship facility in Bengaluru

Stelis Biopharma has received Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA) specific to drug-device combination products to be commercialised at Stelis’s flagship facility in Bengaluru, the company said in a statement.

It also mentioned that this abbreviated Quality System Inspection Technique (QSIT) drug pre-approval on-site inspection was specifically conducted by the USFDA for the drug-device combination products that are to be manufactured/commercialised at the site for the partner products by Stelis. Previously, the USFDA issued an EIR to Stelis in September 2022 based on on-site Pre-Approval Inspection (PAI) and, consequently, the first product approval for one of its key customers in December 2022.


EIREstablishment Inspection ReportStelis BiopharmaUSFDA
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  • soundos

    great content for published!