New York Blood Center, Inc. – FDA 483, Jul 17, 2026

The FDA inspected New York Blood Center, Inc. in New York, NY, a donor center, and identified three observations. The inspection revealed deficiencies in following written standard operating procedures for blood collection, a failure to make written procedures available to personnel, and inadequate record-keeping that did not always identify the person performing work or provide a complete history of apheresis collections. These issues indicate a need for improved adherence to established protocols and documentation practices.