Stelis Biopharma’s facility receives EIR from USFDA

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.