FDA 483 - New York Blood Center Enterprises - July 06, 2023
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.
New York Blood Center Enterprises in New York, NY, was inspected and cited for multiple deficiencies related to blood and blood component collection, record-keeping, and deviation reporting. Observations included failures to follow standard operating procedures, maintain adequate records, adhere to manufacturer instructions, and report biological product deviations in a timely manner. These issues indicate significant concerns with quality control and traceability in their blood bank and donor center operations.
ID · 254d5867-290f-4b3f-b285-7a63366dcb3a