FDA 483 - NYC Health + Hospitals/Bellevue - May 06, 2022

An FDA inspection of NYC Health + Hospitals/Bellevue's Blood Bank in New York, NY, revealed significant deficiencies in their standard operating procedures and record-keeping practices. The facility failed to consistently follow written procedures for visual inspections of blood products and adequately document temperature monitoring, indicating a lack of control over critical processes. Additionally, records for the storage and distribution of blood components were not concurrently maintained, making it impossible to trace all steps for emergency blood products.