New York Blood Center, Inc. Donor Center of NYBC – FDA EIR, Aug 6, 2018

An FDA inspection of the New York Blood Center, Inc. Donor Center of NYBC in Staten Island, NY, was conducted on August 6, 2018. This routine inspection, part of the FY18 OBPO Division 1 blood bank work plan, aimed to assess compliance with the regulatory framework governing licensed and unlicensed blood banks and related entities (cp 7342.001). The facility operates as a donor collection fixed site, engaged in collecting allogeneic, autologous, and directed whole blood, as well as various apheresis and leukocyte-reduced products, as per its active FDA2830 Blood Establishment Registration & Product Listing. The inspection involved a walk-through of the donor center, review of quality control records, and observation of donor interview, mini-physical, and whole blood collection procedures. Auditors found no deficiencies related to equipment calibration, preventative maintenance, temperature monitoring, or donor screening processes. Notably, a review of the 'Validation Summary Document' for an electronic donor management system confirmed its acceptable implementation. Consequently, no main violations or issues were identified, and no FDA Form 483 (Inspectional Observations) was issued to the firm. This indicates that the New York Blood Center, Inc. Donor Center of NYBC was found to be operating in compliance with applicable regulations, and no specific required actions were mandated by the FDA following this inspection.