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

Source: https://www.keypedia.com/records/483/zizion-group-llc/323f4756-9309-4596-89c8-969ed8840b38

> FDA 483 for Zizion Group, LLC on March 12, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Zizion Group, LLC
- Inspection Date: 2024-03-12
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: 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.

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Company: https://www.keypedia.com/companies/zizion-group-llc/c25f6609-d066-4023-897c-9b9127d093da

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6