FDA 483 - Percussionaire Corporation - August 25, 2022

Percussionaire Corporation in Sandpoint, ID, received a Form FDA 483 with six observations following an inspection. The firm was cited for significant deficiencies including failure to submit an MDR report for a serious device malfunction, inadequate complaint investigations, and lack of justification for not reporting a field action. Additionally, issues were noted with corrective and preventive action procedures, evaluation of out-of-tolerance equipment, and supplier quality management, indicating broad concerns with their quality system.