FDA 483 - Lifesouth Community Blood Centers Inc. - East Alabama Region - July 17, 2019

An FDA inspection of Lifesouth Community Blood Centers Inc. - East Alabama Region in Opelika, AL, revealed a significant issue regarding adherence to standard operating procedures. Specifically, an employee was observed improperly mixing sample tubes during whole blood collection, deviating from both the firm's SOPs and the manufacturer's instructions. This indicates a failure to consistently follow established procedures for critical blood collection processes.