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

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.