Surgical Lighting Manufacturer Fails to Validate Design, Evaluate Complaints
An FDA inspection of surgical lighting manufacturer Sunnex’s Charlotte, North Carolina facility found the firm failed to validate designs for its products.
Sunnex failed to establish written design validation procedures for its surgical and exam lights, and it could not provide device history records, according to the Form 483 inspection report.
The firm lacked a record of its design verification activities for one of its transformers and lacked a process validation plan for its medical lights soldering process.
Service reports for repaired medical lights were missing critical information such as test and inspection data.