FDA 483 - New York Blood Center Enterprises - September 24, 2025

An FDA inspection of New York Blood Center Enterprises in New York, NY, revealed four significant observations. The firm failed to consistently follow its own standard operating procedures for blood collection and did not adhere to manufacturer instructions for supplies. Additionally, there were deficiencies in maintaining quality control and general records, including incomplete documentation reviews and a lack of investigations for deviations and donor complaints, alongside issues with traceability in apheresis collection records due to unidentified operators.