FDA 483 - LifeShare Blood Center - August 09, 2019

Lifeshare Blood Centers, a licensed blood bank in Shreveport, LA, was inspected by the FDA and received a Form 483 with five observations. The inspection revealed significant issues including failures in donor notification for confirmed HIV cases, inadequate investigation of serious donor adverse reactions, and deficiencies in obtaining donor contact information. Additionally, the firm failed to thoroughly review discrepancies related to discarded plasma units and lacked specific written standard operating procedures for creating whole blood derived components.