FDA 483 - Vitalant - May 09, 2019

Vitalant in Memphis, TN, was inspected from May 6-9, 2019, and received a Form 483. The inspection revealed deficiencies related to the proper observation, standardization, and calibration of equipment used in blood and blood component collection. Specifically, a component collection machine was found to be in use without proper leveling, and the firm's SOP lacked instructions for this critical step.