FDA 483 - Donor Center Of Nybc - January 12, 2026
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 Rockville Centre, NY, was inspected and received a Form 483 with four observations. The inspection revealed issues with adherence to manufacturer instructions for blood collection, inadequate record-keeping for quality control and investigations, and failures to follow and make available standard operating procedures for blood and blood component collection. These findings indicate deficiencies in operational control and documentation practices at the donor center.
ID · 61397863-6a8e-4068-9bce-39ae8851eb3d