FDA 483 - OneBlood - Crestview - April 09, 2019

An FDA inspection of Oneblood, Inc. in Crestview, FL, identified two significant issues. The firm failed to perform regularly scheduled alarm checks for equipment used in blood and blood component storage and distribution over a 22-month period. Additionally, the firm failed to obtain proof of identity from a donor, citing a known acquaintance as justification, which was not supported by their SOP.