FDA 483 - Dentsply Sirona Charlotte Innovation Center - January 14, 2020

Sirona Dental, Inc. in Charlotte, NC, an initial importer and refurbisher of medical devices, was issued a Form FDA 483 following an inspection from January 9-14, 2020. The inspection revealed significant deficiencies in the firm's quality system, specifically concerning the documentation of service reports for medical devices and the establishment of adequate calibration procedures for repaired devices. These issues indicate a lack of proper control over device servicing and verification activities.