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

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.