KEDPLASMA LLC – FDA 483, May 20, 2019

BPL Plasma, Inc. in El Paso, TX, was cited for three observations related to donor management and equipment procedures during an FDA inspection. The firm failed to notify donors of all infectious disease test results and did not follow its SOP for donor counseling. Additionally, the firm did not consistently adhere to manufacturer instructions for apheresis instrument cleaning and calibration, and improperly removed donor deferrals for adverse events without required follow-up.