Surgical Lighting Firm Cited for Documentation, Complaints

Poor documentation and failure to evaluate complaints were among the deficiencies observed during an FDA inspection of surgical lighting manufacturer Sunnex’s Charlotte, North Carolina facility.

The facility was unable to provide device history records, according to agency’s inspection report. The firm lacked a record of its design verification activities for a transformer and lacked a process validation plan for its medical lights soldering process.

In addition, complaints involving the possible failure of a device to meet its specifications were not reviewed or evaluated, the 483 said.