# FDA 483 - Heat In A Click LLC - January 24, 2025

Source: https://www.keypedia.com/records/483/heat-in-a-click-llc/14e124b5-1636-4fd6-ae67-b55503c784d0

> FDA 483 for Heat In A Click LLC on January 24, 2025. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Heat In A Click LLC
- Inspection Date: 2025-01-24
- Product Type: device
- Office Name: Florida District Office
- Summary: Heat In A Click LLC, an importer and initial distributor of Class I and II medical devices in Dania, FL, received an FDA Form 483 citing numerous significant quality system deficiencies. The firm lacked established procedures for critical functions such as complaint handling, corrective and preventive actions, MDR reporting, supplier evaluations, acceptance activities, nonconforming product control, storage area management, and document control. Additionally, the company failed to implement Unique Device Identifier (UDI) requirements and provide necessary UDI information to the Global Unique Device Identification Database (GUDID).

## Related Documents

- [483 - 2025-01-08](https://www.keypedia.com/records/483/heat-in-a-click-llc/fa0b061f-dbd6-4ea6-be25-dcc50f55e916)

## Related Officers

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

Company: https://www.keypedia.com/companies/heat-in-a-click-llc/1e4deb0e-45e4-4329-86f0-e289f4df965d

Office: https://www.keypedia.com/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9