FDA 483 - New York Blood Center Enterprises - October 27, 2023

An FDA inspection of New York Blood Center Enterprises in Westbury, NY, revealed significant deficiencies in record-keeping, adherence to standard operating procedures, and data integrity. The firm failed to maintain adequate records for donor sample shipping and plasma processing, and did not consistently follow SOPs for blood product handling, visual inspection, and deviation management. Additionally, issues were noted with electronic data system record maintenance and the proper use of supplies and reagents according to manufacturer instructions.