# FDA 483 - Hamilton Medical AG - July 18, 2022

Source: https://www.globalkeysolutions.net/records/483/hamilton-medical-ag/4ce38211-3e42-4862-b5d4-fb2e2b8a2230

> FDA 483 for Hamilton Medical AG on July 18, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hamilton Medical AG
- Inspection Date: 2022-07-18
- Product Type: device
- Office Name: International Compliance Team
- Summary: Hamilton Medical AG, a medical device manufacturer, was cited for significant quality system deficiencies during an FDA inspection. The firm failed to establish adequate procedures for medical device reporting, resulting in unsubmitted malfunction reports for ventilators. Additionally, issues were noted in complaint handling, corrective and preventive action processes, and the completeness of device history records.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/stephen-d-eich/a932e816-cbe3-4f1c-84e7-8a81cc8b529e)

Company: https://www.globalkeysolutions.net/companies/hamilton-medical-ag/371dc527-8309-462e-a76a-571570f30cb4

Office: https://www.globalkeysolutions.net/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321