New York Blood Center Enterprises – FDA 483, Jul 8, 2026

An FDA inspection of New York Blood Center Enterprises in Westbury, NY, revealed four observations related to the handling and record-keeping of blood products. Deficiencies included failure to follow standard operating procedures for temperature control during blood product processing and distribution, use of damaged equipment for temperature checks, and inadequate record maintenance for blood product inventory and ISBT labels. These issues indicate a need for improved adherence to established procedures and record-keeping practices.