FDA 483 - Wellness Without Limits LLC - October 17, 2023

Wellness Without Limits LLC, an initial importer in Melbourne, FL, was cited for significant deficiencies in its quality system during an FDA inspection. The inspection revealed a complete absence of written procedures for critical processes including Medical Device Reporting (MDR), corrective and preventive actions (CAPA), and complaint handling. These observations indicate a fundamental lack of established controls necessary for ensuring product quality and regulatory compliance.