FDA 483 - Methodist Hospital Blood Bank - March 18, 2026

Methodist Hospital Blood Bank in San Antonio, TX, received a Form 483 with two observations related to equipment maintenance and record-keeping. The inspection revealed failures in regularly scheduled maintenance and calibration of blood processing equipment, specifically an irradiator. Additionally, the facility failed to properly document and manage a malfunctioning blood product freezer, including lack of work orders and incident reports, which led to temperature excursions affecting stored blood products.