# FDA 483 - Scholly Fiberoptic GmbH - September 28, 2023

Source: https://www.keypedia.com/records/483/scholly-fiberoptic-gmbh/f5f1deea-c260-4995-b008-7f238472f527

> FDA 483 for Scholly Fiberoptic GmbH on September 28, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Scholly Fiberoptic GmbH
- Inspection Date: 2023-09-28
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: Scholly Fiberoptic GmbH, a medical device manufacturer in Denzlingen, Germany, was cited for significant deficiencies in its quality system during an FDA inspection. The firm's corrective and preventive action procedures were found ineffective, leading to recurring product issues. Additionally, complaint handling procedures failed to adequately evaluate complaints for Medical Device Reporting, and device history records were incomplete regarding labeling information.

## Related Officers

- [Katherina M. Tarnai](https://www.keypedia.com/people/katherina-m-tarnai/1b886d5f-dbb2-4b32-a31c-56902d7715c6)
- [company_representative](https://www.keypedia.com/people/michael-d-angelo/9c6eb843-c96c-4955-93e6-0cbd821236ec)

Company: https://www.keypedia.com/companies/scholly-fiberoptic-gmbh/626a52d0-9c23-4f10-9958-62decb30f0b5

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b