# FDA 483 - MAXXION TECHNOLOGY , LLC - June 08, 2023

Source: https://www.keypedia.com/records/483/maxxion-technology-llc/9c2fecbb-82d2-4a98-b5ba-143da8128737

> FDA 483 for MAXXION TECHNOLOGY , LLC on June 08, 2023. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: MAXXION TECHNOLOGY , LLC
- Inspection Date: 2023-06-08
- Product Type: other
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: MAXXION TECHNOLOGY, LLC in Doral, FL, was inspected from June 7-8, 2023, revealing a significant issue with record accessibility. The firm failed to maintain required quality policy, procedures, and records at a location reasonably accessible to both company officials and FDA employees, stating they were located at a manufacturing facility in Brazil. This constitutes a fundamental violation of recordkeeping requirements.

## Related Officers

- [investigator](https://www.keypedia.com/people/ronald-ifraimov/b4ce8b79-3fa2-4862-b7a4-68e14e45d87a)

Company: https://www.keypedia.com/companies/maxxion-technology-llc/d6f54b5c-66dd-45a8-b9bb-a43691f5abbb

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