# FDA 483 - Atmos Medizintechnik Gmbh & Co. KG - September 16, 2022

Source: https://www.keypedia.com/records/483/atmos-medizintechnik-gmbh-co-kg/825b7330-e1dd-4381-81c2-a6491af853cb

> FDA 483 for Atmos Medizintechnik Gmbh & Co. KG on September 16, 2022. 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: 2022-09-16
- Product Type: device
- Office Name: New Jersey District Office
- Summary: Atmos Medizintechnik Gmbh & Co. KG, a medical device manufacturer in Lenzkirch, Germany, was cited with 25 observations during an FDA inspection. The inspection revealed a pervasive lack of established procedures across nearly all critical quality system elements, including design control, CAPA, complaint handling, training, and production controls. This indicates a fundamental deficiency in the firm's quality management system.

## Related Officers

- [CDR Octavia C. Young, Investigator](https://www.keypedia.com/people/cdr-octavia-c-young-investigator/b77ede06-c70d-4242-9435-e55c7106f2d8)
- [LTJG Michael D. Eber, Investigator](https://www.keypedia.com/people/ltjg-michael-d-eber-investigator/4761c466-75a7-451e-b1ed-a108d3fdf362)

Company: https://www.keypedia.com/companies/atmos-medizintechnik-gmbh-co-kg/afcccd87-4ec1-4c14-8f7d-2958f775bcf1

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248