483
University Medical Center Transfusion ServiceUniversity Medical Center Transfusion Service – FDA 483, Jul 23, 2019
Record Details
The FDA inspected the University Medical Center Transfusion Service in Lubbock, TX, from July 22-23, 2019. The inspection identified a significant issue with record-keeping, specifically the failure to maintain concurrent records for the storage and distribution of blood and blood components. This deficiency resulted in the inability to trace the final disposition of specific plasma and platelet units.
- Inspection date
- July 23, 2019
- Product type
- biologics
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ID · 9ef82117-c8ed-4281-a542-ec53f16d369b
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