# FDA 483 - Atmos Medizintechnik Gmbh & Co. KG - January 26, 2023

Source: https://www.keypedia.com/records/483/atmos-medizintechnik-gmbh-co-kg/d65654e0-fa14-4bf7-84fd-3bde34879957

> FDA 483 for Atmos Medizintechnik Gmbh & Co. KG on January 26, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Atmos Medizintechnik Gmbh & Co. KG
- Inspection Date: 2023-01-26
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Atmos Medizintechnik Gmbh & Co. KG, a medical device manufacturer in Lenzkirch, Germany, revealed a significant deficiency in their quality system. The firm failed to establish procedures for design control, encompassing critical elements such as design planning, input, output, review, verification, validation, transfer, and changes. This indicates a fundamental lack of control over the design and development process for their medical devices.

## Related Officers

- [David Lennarz](https://www.keypedia.com/people/david-lennarz/7524fe46-01da-49a0-b6c1-45210bf91809)
- [Michael J. Shaffer](https://www.keypedia.com/people/michael-j-shaffer/6a684281-70e9-4bc3-9039-5e2121506817)

Company: https://www.keypedia.com/companies/atmos-medizintechnik-gmbh-co-kg/b61c4cd7-07d8-40b7-9e20-c5acbb87f3f0

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6