FDA 483 - New York Blood Center Enterprises - April 23, 2026

An FDA inspection of New York Blood Center Enterprises in Ronkonkoma, NY, a donor center, revealed that written standard operating procedures for the collection of blood and blood components were not consistently followed. Specifically, issues were noted with the initiation of apheresis collection after sampling and the proper leveling of collection instruments. These findings indicate procedural deviations in critical blood collection processes.