FDA 483 - IT Synergistics, LLC - June 23, 2020

IT Synergistics, LLC, a manufacturer of blood establishment computer software in Flowood, MS, was cited with 10 observations during an FDA inspection. The inspection revealed significant deficiencies across its quality system, particularly concerning complaint handling, CAPA, design controls, management review, and quality audits for its LifeTec Elite and DoVac Elite software products. These issues indicate a fundamental lack of established procedures and oversight for critical quality system elements.