FDA 483 - Newark Beth Israel Medical Center - Blood Bank - October 13, 2023

An FDA inspection of Newark Beth Israel Medical Center - Blood Bank revealed significant deficiencies in adhering to written standard operating procedures and maintaining accurate records. The firm failed to follow procedures for blood irradiator verification and quality control, resulting in incomplete and inaccurate documentation. Additionally, records for processing blood and blood components were not concurrently maintained, lacking crucial details for traceability.