FDA 483 - DS REP B.V. - June 16, 2022

An FDA inspection of Dentsply Sirona Prosthetics in Las Piedras, PR, from June 13-16, 2022, revealed two significant issues. The firm failed to adequately establish procedures for ensuring purchased products and services conform to specified requirements, including a lack of defined supplier requirements and unimplemented quality agreements. Additionally, the inspection found that personnel training, specifically for an employee conducting manufacturing operations, was not documented.