# FDA 483 - Absolute Medical GmbH - Unknown Date

Source: https://www.keypedia.com/records/483/absolute-medical-gmbh/23994da2-041c-42b4-8fb9-d0ee84eb7e1d

> FDA 483 for Absolute Medical GmbH on Unknown Date. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Absolute Medical GmbH
- Product Type: device
- Office Name: International Compliance Team
- Summary: An FDA inspection of Absolute Medical GmbH in Borken, Germany on August 2, 2024, revealed two significant observations. The firm failed to adequately validate a process for dental implant products and did not establish adequate procedures for corrective and preventive actions, specifically lacking documentation of corrective action effectiveness.

## Related Officers

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

Company: https://www.keypedia.com/companies/absolute-medical-gmbh/b01b6857-0a88-46f8-961b-13e877f34156

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