FDA 483 - Forbes Rehab Services Inc - December 20, 2024

Forbes Rehab Services Inc, a manufacturer of Augmentative Alternative Communication (AAC) devices in Mansfield, OH, was cited for significant deficiencies in its quality system. The inspection revealed failures in establishing and following procedures for corrective and preventive actions, design changes, and complaint handling. Additionally, the firm did not adequately review, investigate, or report complaints that appeared to be Medical Device Report (MDR) reportable adverse events.