FDA 483 - Compumedics USA, Inc - September 16, 2021
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.
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.
- Office
- Atlanta District Office
- Person
ID · 79a53763-e000-4a57-b0bd-8bcec8027d10