FDA 483 - Compumedics USA, Inc - September 16, 2021

An FDA inspection of Compumedics USA, Inc. in Charlotte, NC, from September 8-16, 2021, identified 10 significant quality system deficiencies, many of which were repeat observations. The firm was cited for inadequate complaint handling, incomplete service and installation records, and insufficient corrective and preventive actions. Additional issues included a lack of a designated management representative, unperformed quality audits, and deficiencies in management review documentation and employee training.