FDA 483 - Nassau Health Care Corporation d/b/a/ NuHealth - September 19, 2022

Nassau Health Care Corporation d/b/a/ NuHealth, a blood bank/donor center in East Meadow, NY, was cited for deficiencies related to its standard operating procedures for blood collection and processing. The inspection revealed issues with donor arm inspections and the lack of SOPs for low volume whole blood units, alongside failures in maintaining complete processing records for blood units. These observations indicate a need for improved procedural adherence and documentation practices.