Sunnex, LLC – FDA 483, Feb 18, 2022

Sunnex, LLC, a manufacturer of surgical light devices in Charlotte, NC, received an FDA Form 483 with 11 observations, many of which were repeats from a previous inspection. The observations primarily concern significant deficiencies in design controls, including validation, verification, transfer, and planning, as well as inadequate process validation, complaint handling, training, and document control. The firm also failed to properly analyze service reports and maintain complete device history records.