# FDA 483 - Efunctional LLC - March 07, 2024

Source: https://www.keypedia.com/records/483/efunctional-llc/265db93f-fdfe-4faa-a016-e7422825070b

> FDA 483 for Efunctional LLC on March 07, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Efunctional LLC
- Inspection Date: 2024-03-07
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Efunctional LLC, a medical device manufacturer in Davie, FL, was inspected by the FDA from March 5-7, 2024. The inspection revealed significant deficiencies across its quality system, indicating a lack of established procedures for critical functions such as complaint handling, non-conformance control, CAPA, device history records, supplier management, training, quality audits, and management review. These findings suggest a foundational absence of a robust quality management system.

## Related Officers

- [Matthew T. Sanchez](https://www.keypedia.com/people/matthew-t-sanchez/40cb1906-d951-4274-8b34-6ce30b76e32b)
- [Ebony D. Sanon](https://www.keypedia.com/people/ebony-d-sanon/703dc125-1019-43d1-9598-1bdc92026e2b)

Company: https://www.keypedia.com/companies/efunctional-llc/9b7d350a-1375-42c4-b2a1-f38bbbfa7d13

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