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

Source: https://www.keypedia.com/records/483/wellness-without-limits-llc/ea153408-3f3b-4474-ae89-d4688a3b05bf

> FDA 483 for Wellness Without Limits LLC on October 17, 2023. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Wellness Without Limits LLC
- Inspection Date: 2023-10-17
- Product Type: other
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: 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.

## Related Documents

- [483 - 2023-10-17](https://www.keypedia.com/records/483/wellness-without-limits-llc/f4ecf57f-7ab4-4bcb-acec-1936d2843c47)

## Related Officers

- [Alex J. Wild](https://www.keypedia.com/people/alex-j-wild/bb1b66b3-19b9-480e-af0b-f06f8de0d930)

Company: https://www.keypedia.com/companies/wellness-without-limits-llc/3619f1c2-657e-4d11-9020-995052e69ef3

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