FDA 483 - Barkey GmbH & Co. KG - November 04, 2022

An FDA inspection of Barkey GmbH & Co. KG in Leopoldshohe, Germany, revealed significant deficiencies in the firm's design control procedures for their Class II device, Barkey Plasmatherm V 292. The observations primarily focused on inadequate validation, risk analysis, and documentation related to a design change. Additionally, issues with device history records and control of nonconforming products were noted.