FDA 483 - Love Rehab Solutions Inc - December 17, 2019

Love Rehab Solutions, a medical device manufacturer in Oxford, GA, was inspected by the FDA. The inspection revealed significant deficiencies in their quality system, including a lack of established procedures for various critical functions like complaint handling, MDRs, CAPA, design control, process control, and acceptance activities. Additionally, the firm failed to establish and maintain essential device documentation such as the design history file, device master record, and device history records for their safety beds.