FDA 483 - BioLife Plasma Services L.P. - March 20, 2026

BioLife Plasma Services L.P. in Sacramento, CA, a Source Plasma establishment, was inspected and cited for significant deficiencies in donor screening and plasma suitability procedures. The inspection revealed failures in systematically evaluating donor pulse regularity, inadequate standard operating procedures, improper delegation of physician duties, and the release of unsuitable plasma units. Additionally, the firm failed to notify deferred donors of their status in a timely manner.