# FDA 483 - SensiMedical LLC - January 19, 2024

Source: https://www.keypedia.com/records/483/sensimedical-llc/c92f9089-d704-408f-af8f-7038d6ffe0f0

> FDA 483 for SensiMedical LLC on January 19, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SensiMedical LLC
- Inspection Date: 2024-01-19
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: SensiMedical LLC, an initial importer in Miami, FL, was inspected regarding its Class II sterile medical devices. The inspection revealed a significant deficiency where the firm failed to establish a design history file and adequate design control procedures for its intravascular administration sets, despite continuing to distribute these devices. This indicates a serious lack of compliance with medical device regulations.

## Related Officers

- [Ebony D. Sanon](https://www.keypedia.com/people/ebony-d-sanon/703dc125-1019-43d1-9598-1bdc92026e2b)

Company: https://www.keypedia.com/companies/sensimedical-llc/fec8d512-5acd-412b-94b3-155a791793d1

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