FDA 483 - Forbes Rehab Services Inc - December 20, 2024
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
ID · 0c21f6bd-caf5-4bff-b396-a80cabd0c7b1