Stelis Biopharma has received Establishment Inspection Report (EIR) from the United States Food and Drug Administration (US FDA) specific to drug-device combination products to be commercialised at Stelis’ flagship facility in Bengaluru.

It also mentioned that this abbreviated Quality System Inspection Technique (QSIT) drug pre-approval on-site inspection was specifically conducted by the US FDA for the drug-device combination products that are to be manufactured/commercialised at the site for the partner products by Stelis.

Previously, the US FDA 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.

Stelis, which is a fully integrated biopharmaceutical contract development and manufacturing organisation (CDMO), had the US FDA conduct an Abbreviated Quality System Inspection Technique (QSIT) drug pre approval on-site inspection