FDA 483 - Central California Blood Center - September 26, 2019

An FDA inspection of Central California Blood Center in Fresno, CA, identified significant deficiencies in the establishment, maintenance, and adherence to written standard operating procedures for blood and blood component processing. Issues included improper irradiator usage, a lack of procedures for monitoring irradiation cycle times, and failures in the review and documentation of donor reaction records. These observations highlight a need for improved procedural compliance and record-keeping to ensure the safety and quality of blood products.