Orca Biosystems, Inc. – FDA 483, Sep 20, 2026

An FDA inspection of Orca Biosystems, Inc. in Sacramento, California, revealed significant deficiencies in laboratory controls for their Hematopoietic Stem and Progenitor Cell (HSPC), Regulatory T Cell (Treg), and Conventional T Cell (Tcon) drug products. Specifically, quality control assay procedures, standard operating procedures, and work instructions lacked detailed steps and adequate controls, rendering release testing results unreliable and irreproducible. These issues could compromise product quality decisions and patient safety.