FDA 483 - Stony Brook University Medical Center - February 07, 2023

An FDA inspection of Stony Brook University Medical Center's blood bank revealed significant deficiencies in reporting, record-keeping, and standard operating procedures. The facility failed to submit biological product deviation reports for numerous incidents involving blood product expiration dates, mislabeling, and incorrect patient issuance. Additionally, the inspection found inadequate quality control records for blood warmers and incomplete SOPs for blood collection, storage, and distribution, including donor screening and product visual inspection.