Compumedics USA, Inc – FDA 483, Mar 5, 2019

This FDA Form 483 report details an inspection of Consumedics USA, Inc. in Charlotte, NC, a firm engaged in repacking and relabeling medical devices. The inspection revealed significant deficiencies across multiple quality system areas, including inadequate procedures for servicing, installation, calibration, CAPA, complaint handling, and incoming product acceptance. These observations indicate a broad lack of established and documented quality control processes for medical devices.