FDA 483 - Versiti Michigan Inc - October 30, 2019

An FDA inspection of Versiti Michigan Inc. in Saginaw, MI, from October 26-30, 2019, revealed significant deviations from written standard operating procedures. Staff failed to consistently follow procedures during automated apheresis collection and donor screening, impacting alarm responses, documentation, needle adjustments, and donor vital sign measurements. These findings indicate a lack of adherence to established protocols for blood and blood component collection.