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

Source: https://www.keypedia.com/records/483/barkey-gmbh-co-kg/26d02f40-e8d3-4624-9327-1b20ce02e042

> FDA 483 for Barkey GmbH & Co. KG on November 04, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Barkey GmbH & Co. KG
- Inspection Date: 2022-11-04
- Product Type: device
- Office Name: Office of Biological Products Operations - Division I
- Summary: 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.

## Related Documents

- [WARNING_LETTER - 2022-11-04](https://www.keypedia.com/records/warning_letter/barkey-gmbh-co-kg/bf373759-c174-4b4a-9841-f063bef5b22c)

## Related Officers

- [Investigator](https://www.keypedia.com/people/shafiq-s-ahadi/dd146b0a-ca1c-4052-8f50-4d68e14ad73f)

Company: https://www.keypedia.com/companies/barkey-gmbh-co-kg/b3a72fad-2cfe-4559-b561-0f6f8dbbeed7

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1