FDA 483 - Vitalant Reference and Transfusion Service - August 05, 2019
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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.
ID · 16f6e778-b170-4707-87fb-676a32d88821