FDA 483 - SeaStar Medical, Inc. - February 27, 2025

SeaStar Medical, Inc. in Denver, CO, a medical device manufacturer, was cited for a significant deficiency during an FDA inspection. The firm failed to perform the required process validation, specifically the Performance Qualification, for its Quelimmune Selective Cytopheretic Device for Pediatrics (SCD-PED) Clinical Kits. This indicates a lack of assurance that a critical manufacturing process consistently produces a product meeting its predetermined specifications.