FDA 483 - Vitalant Reference and Transfusion Service - August 05, 2019

An FDA inspection of UPMC Clinical Services, a Hospital Blood Bank in Pittsburgh, identified significant deficiencies in record-keeping practices. Observations included a failure to maintain complete records for emergency transfusions, specifically regarding physician signatures. Additionally, the firm's maintenance logs were found to be incomplete, lacking dates, management reviews, and technician initials, indicating a systemic issue with documentation accuracy and completeness.