FDA 483 - VA Health Care System (113) - June 13, 2025

An FDA inspection of Fargo VA Healthcare System's Blood Bank revealed significant deficiencies in their quality system. The firm failed to establish, maintain, and follow written standard operating procedures for investigating product deviations, specifically lacking a Corrective and Preventive Action (CAPA) process. This led to critical issues such as the use of expired reagents for quality control and patient testing, and the omission of required quality control procedures.