FDA EIR - New York Blood Center Inc - August 19, 2019

An FDA surveillance inspection of New York Blood Center, Inc., located in New York, NY, was conducted from August 16 to August 19, 2019. The inspection, guided by CPGM 7342.001 for blood establishments, focused on donor eligibility, product collection, and quality assurance systems at this fixed donor center. The facility is registered to collect various blood products, including whole blood and apheresis components. During the inspection, no FDA-483 (Inspectional Observations) was issued, indicating no significant deficiencies requiring immediate corrective action were formally cited. The previous inspection's discussion items, concerning the absence of on-site CPR-certified staff and an unsigned preventative maintenance report, were not re-observed, signifying resolution. However, a key discussion item arose regarding the firm's practice of not consistently obtaining a postal address where donors could be contacted for eight weeks post-donation. The investigator emphasized the importance of this timeframe for donor notification, noting that current address verification might not account for changes (e.g., students or military personnel). Management, including Team Leader Ms. Wagaye Bauer and Quality Specialist Ms. Michele Linzalone, acknowledged this concern. They stated that New York Blood Center was in the process of revising its "NY-JA-0210 Donor Instructions for Completion of Self-Administered English" to address this requirement, with implementation anticipated around September 2019, to ensure robust donor contact information for critical follow-up.