# FDA 483 - Absolute Medical GmbH - August 02, 2024

Source: https://www.keypedia.com/records/483/absolute-medical-gmbh/be00aa6c-c6da-4b70-afca-4f942cebc274

> FDA 483 for Absolute Medical GmbH on August 02, 2024. Product: Device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Absolute Medical GmbH
- Inspection Date: 2024-08-02
- Product Type: Device
- Office Name: Center for Devices and Radiological Health
- Summary: **FDA 483 Summary for Absolute Medical GmbH**

**Inspection Details:**
- **Company:** Absolute Medical GmbH
- **Inspection Date:** August 2, 2024
- **Location:** Borken, Germany
- **Type of Establishment:** Device Manufacturer

**Main Violations/Issues:**
1. **Process Validation:** The FDA observed that Absolute Medical GmbH failed to adequately validate a critical process related to the manufacturing of dental implant products. Specifically, the process outlined in work instruction AA-009 did not consistently meet product specifications, as demonstrated during its use in May 2024.
   
2. **Corrective and Preventive Actions (CAPA):** The company’s procedures for corrective and preventive actions were found lacking. The system used for addressing customer complaints did not adequately document the effectiveness of corrective actions taken.

**Regulatory Framework:**
The observations are based on the FDA’s quality system requirements, which mandate that device manufacturers ensure their processes are validated and that corrective actions are effective.

**Required Actions:**
Absolute Medical GmbH is responsible for conducting internal audits to identify and rectify all violations of quality system requirements. The company is expected to implement corrective actions to address the noted deficiencies and ensure compliance. Discussions with FDA representatives regarding objections or corrective actions are encouraged.

**Contact Information:**
For further inquiries or to submit additional information, contact the FDA at the address and phone number provided in the document.

**Issued By:**
Stephen D. Eich, FDA Investigator, on August 2, 2024.

## Related Documents

- [483 - Unknown Date](https://www.keypedia.com/records/483/absolute-medical-gmbh/23994da2-041c-42b4-8fb9-d0ee84eb7e1d)

## 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/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7