USFDA issues EIR specific to drug-device combination products to be commercialized at Stelis' Bengaluru unit

Stelis Biopharma (Stelis or Company), an emerging biopharmaceutical Contract Development and Manufacturing Organization (CDMO) and the biologics arm of Strides Pharma Science announced that it has received Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (USFDA or FDA or Agency) specific to Drug-Device Combination Products to be commercialized at Stelis' flagship facility in Bengaluru, India.

This Abbreviated Quality System Inspection Technique (QSIT) drug preapproval on-site inspection was specifically conducted by the USFDA for the drug-device combination products that are to be manufactured/ commercialized 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.

 

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