# FDA 483 - MAXOGEN GROUP LLC - June 05, 2023

Source: https://www.globalkeysolutions.net/records/483/maxogen-group-llc/adb59564-4984-4881-80fa-6e3753b359c0

> FDA 483 for MAXOGEN GROUP LLC on June 05, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: MAXOGEN GROUP LLC
- Inspection Date: 2023-06-05
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: MAXOGEN GROUP LLC, a specification developer in Hollywood, FL, received a Form FDA 483 with 10 observations during an inspection. The firm demonstrated significant deficiencies across its quality system, including failures to implement procedures for CAPA, complaint handling, design control, device records, non-conforming products, MDRs, supplier management, management reviews, and internal audits. These issues indicate a fundamental lack of a functional quality system for its Class II medical device, Bite Helper.

## Related Officers

- [Ebony D. Sanon](https://www.globalkeysolutions.net/people/ebony-d-sanon/703dc125-1019-43d1-9598-1bdc92026e2b)

Company: https://www.globalkeysolutions.net/companies/maxogen-group-llc/c41744a7-25ab-4108-8d0b-d0295d89fc99

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