483
Zizion Group, LLCFDA 483 - Zizion Group, LLC - March 12, 2024
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
Record Details
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.
Open in Dashboard
ID · 323f4756-9309-4596-89c8-969ed8840b38