NYU Langone Health Hospital – FDA 483, Jan 17, 2025

During an inspection conducted from January 8-17, 2025, the FDA issued a Form 483 to NYU Langone Health Hospital, citing several objectionable conditions and practices. The observations primarily concerned the facility's blood bank operations and highlight non-compliance with regulatory requirements under the Federal Food, Drug, and Cosmetic Act.

Key issues included deficiencies in written standard operating procedures (SOPs) for the storage and distribution of blood components. Specifically, documented visual inspections of blood products were not always performed, incident investigations lacked documented preventive actions, and SOPs were not updated to reflect current aliquot preparation practices. The inspection also identified a lack of proper record-keeping for tracing product distribution, such as Red Blood Cell storage from receipt to processing. Furthermore, temperature controls during the shipment of Red Blood Cells were not consistently maintained within the required 1-10°C range. Additional findings included a failure to maintain processing and quality control records, particularly for whole blood reconstitution calculations, and the improper use of supplies and reagents. This included a lack of calibration records for temperature monitoring devices and failure to document the benchtop residence time for patient blood testing reagents as per manufacturer instructions.

NYU Langone Health Hospital is required to address these observations by implementing comprehensive corrective and preventive actions to ensure compliance with federal regulations governing blood product handling and quality systems.