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

An FDA inspection was conducted at NYU Langone Health Hospital from January 8-17, 2025, with observations issued to Chief Medical Officer Nicole M. Adler, MD. The inspection revealed several issues indicating non-compliance with federal regulations governing the handling, storage, and distribution of blood and blood components, falling under the purview of the Federal Food, Drug and Cosmetic Act.

Key violations included a failure to consistently establish, maintain, and follow written standard operating procedures (SOPs). Specific instances noted were the inadequate performance or documentation of visual inspections for blood product appearance and expiration before issuance, and inconsistent documentation of preventive actions following incidents like incorrect platelet aliquot volumes or mislabeled expiration dates.

Additional issues involved insufficient record-keeping for tracing blood product distribution, particularly for Red Blood Cells from initial receipt to processing. The facility also failed to maintain Red Blood Cell transport temperatures within the required 1-10°C range on several occasions in 2023 and 2024. Furthermore, critical processing, quality control, and general records, such as calculations for whole blood reconstitution, were unavailable. Finally, supplies and reagents were not used according to manufacturer instructions, evidenced by missing calibration records for temperature monitoring devices and a lack of documentation for the duration certain testing reagents were on instruments. The hospital is expected to implement thorough corrective and preventive actions to address these observations and ensure compliance with FDA regulations for blood establishments.