# FDA 483 - Logozys Logistik GmbH - June 15, 2022

Source: https://www.keypedia.com/records/483/logozys-logistik-gmbh/17a6cc52-9d9a-4467-b8ad-d5c119e49d34

> FDA 483 for Logozys Logistik GmbH on June 15, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Logozys Logistik GmbH
- Inspection Date: 2022-06-15
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Logozys Logistik GmbH in Darmstadt, Hesse, Germany, from June 13-15, 2022, identified one observation. The firm was cited for inadequate documentation of process validation activities. This indicates a deficiency in their quality system documentation practices.

## Related Officers

- [investigator](https://www.keypedia.com/people/john-a-sciacchitano/9f8f49bf-1971-449e-972e-b516418ea78e)

Company: https://www.keypedia.com/companies/logozys-logistik-gmbh/7ca6b8b9-ba3c-4dc6-8d4d-40d9868c2150

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd