# FDA 483 - Occlutech GmbH - June 02, 2022

Source: https://www.globalkeysolutions.net/records/483/occlutech-gmbh/bb81f29f-c614-4989-90b2-e852efdbb215

> FDA 483 for Occlutech GmbH on June 02, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Occlutech GmbH
- Inspection Date: 2022-06-02
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Occlutech GmbH in Jena, Germany, revealed two significant quality system deficiencies. The firm was cited for inadequate process validation and deficiencies in its corrective and preventive action procedures. These observations indicate a need for improved quality management practices at the medical device manufacturer.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/occlutech-gmbh/f69e1580-3013-4238-b03e-af828fce6075

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