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483
•B Positive National Blood Services - Cheltenham, LLC•August 24, 2022

B Positive National Blood Services - Cheltenham, LLC – FDA 483, Aug 24, 2022

Record Details

B Positive National Blood Services - Cheltenham, LLC, a plasma center, was cited with two observations during an FDA inspection. The firm failed to ensure that the responsible physician approved the reinstatement of deferred donors with abnormal protein test results. Additionally, the facility did not store reagents and supplies according to manufacturer instructions or monitor their storage temperatures.

Company
B Positive National Blood Services - Cheltenham, LLC
Inspection date
August 24, 2022
Product type
biologics
Office
Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
People
  • Thaddeus Nndube
  • Christopher Sy
View Company Profile

ID · 6006e660-aed4-43f3-8065-624c24ed00b5

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