FDA 483 - Prentke Romich Company DBA PRC-Saltillo - May 01, 2025

Prentke Romich Company DBA PRC-Saltillo, a manufacturer of augmentative alternative communication devices in Wooster, OH, was inspected and received five observations. The inspection revealed significant deficiencies in software validation, documentation of field corrections, corrective and preventive actions, complaint handling procedures, and device history records. These issues indicate a moderate level of non-compliance with quality system regulations.