FDA 483 - KedPlasma LLC

KEDPLASMA LLC, a plasmapheresis facility in Atlanta, Georgia, received a Form FDA 483 following an inspection from March 19-21, 2019. The inspection revealed two significant observations related to donor notification and adherence to standard operating procedures. Specifically, the firm failed to adequately notify deferred donors of all positive test results and did not consistently follow its SOPs for manufacturing Source Plasma, recordkeeping, equipment checks, and managing donor adverse events.