Barkey GmbH & Co. KGNovember 4, 2022

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

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Record Details

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.

Company: Barkey GmbH & Co. KG
Inspection Date: November 4, 2022
Product Type: Device
Office: Office of Biological Products Operations - Division I
Person: Shafiq S. Ahadi (Investigator)

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ID · 26d02f40-e8d3-4624-9327-1b20ce02e042