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

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.