FDA 483 - Zizion Group, LLC - March 12, 2024

Zizion Group, LLC, a medical device manufacturer in Boca Raton, FL, was cited for significant deficiencies in its quality system during an FDA inspection. The firm failed to adequately establish and follow procedures for complaint handling and storage area control, and its medical device labels lacked unique device identifiers. These issues indicate a lack of adherence to regulatory requirements for device manufacturing and quality management.