FDA 483 - New York Blood Center Enterprises - September 24, 2025
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
ID · 7550c6b5-2566-4795-bb58-7790564154ff