# FDA 483 - August Reuchlen GmbH - May 02, 2025

Source: https://www.keypedia.com/records/483/august-reuchlen-gmbh/9cd16409-a00b-470b-972d-7b567901665e

> FDA 483 for August Reuchlen GmbH on May 02, 2025. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: August Reuchlen GmbH
- Inspection Date: 2025-05-02
- Product Type: other
- Office Name: Office of Medical Device and Radiological Health Operations
- Summary: An FDA inspection of August Reuchlen GmbH, a manufacturer in Tuttlingen, Germany, identified two significant issues. The firm failed to adequately document corrective and preventive action activities and results. Additionally, the company's supplier control procedures did not clearly define the type and extent of control to be exercised over contractors and consultants.

## Related Officers

- [investigator](https://www.keypedia.com/people/john-a-sciacchitano/9f8f49bf-1971-449e-972e-b516418ea78e)
- [Dedicated Device Cadre](https://www.keypedia.com/people/dedicated-device-cadre/693932db-dd86-453f-9b51-a63444b07281)

Company: https://www.keypedia.com/companies/august-reuchlen-gmbh/9c0c3b5f-2ee2-4e98-ab6c-a52d3ea79a60

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-operations/27658190-735a-443e-9087-3534cfe74fd4