# FDA 483 - Orfit Industries NV - May 17, 2018

Source: https://www.keypedia.com/records/483/orfit-industries-nv/0394cba2-3ac9-483f-ba0f-2e2f4ca3a250

> FDA 483 for Orfit Industries NV on May 17, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Orfit Industries NV
- Inspection Date: 2018-05-17
- Product Type: device
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Orfit Industries NV, a medical device manufacturer in Wijnegem, Belgium, revealed significant deficiencies in their quality system. Observations included inadequate documentation of design review results for the RT-131, Mammo RX Breast Board, and insufficient frequency and documentation of management reviews. Additionally, the firm failed to perform quality audits covering all elements of the quality system, indicating a need for improved adherence to regulatory requirements.

## Related Officers

- [investigator](https://www.keypedia.com/people/yehualashet-a-gessesse/cb732900-358c-4982-a912-e98fa45142fe)

Company: https://www.keypedia.com/companies/orfit-industries-nv/3ec06979-5df4-4961-97b7-eccebb8ed53e

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1