# FDA 483 - R & Y GROUP, LLC - December 15, 2022

Source: https://www.keypedia.com/records/483/r-y-group-llc/2b09d99b-323a-44e7-a498-9c6f334efa91

> FDA 483 for R & Y GROUP, LLC on December 15, 2022. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: R & Y GROUP, LLC
- Inspection Date: 2022-12-15
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of R & Y GROUP, LLC in Miami, FL, an initial importer and private label distributor of reusable cold/hot pack devices, revealed significant deficiencies in their quality system. The firm failed to establish procedures for receiving, reviewing, and evaluating complaints, and also lacked written Medical Device Reporting (MDR) procedures. These issues are serious as they relate to the firm's ability to handle customer complaints, including reports of skin burns, and to report adverse events as required by regulations.

## Related Officers

- [investigator](https://www.keypedia.com/people/stanley-b-eugene/4708f43e-0592-4c24-b276-d9f9092788a3)

Company: https://www.keypedia.com/companies/r-y-group-llc/8b840cad-a1dd-4e99-bcb7-4f6cd9f8e181

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