# FDA 483 - b-Eye srl - October 11, 2018

Source: https://www.keypedia.com/records/483/b-eye-srl/59b31880-dcfb-411d-96e5-0de6e4dacde5

> FDA 483 for b-Eye srl on October 11, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: b-Eye srl
- Inspection Date: 2018-10-11
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of b-Eye srl, a device manufacturer in Padova, Italy, revealed significant deficiencies in their quality system. Observations included inadequate procedures for design input, incomplete documentation for corrective and preventive actions, and a lack of established procedures for the review and disposition of nonconforming products. These issues indicate a need for improved quality management system controls.

## Related Officers

- [investigator](https://www.keypedia.com/people/john-a-sciacchitano/9f8f49bf-1971-449e-972e-b516418ea78e)

Company: https://www.keypedia.com/companies/b-eye-srl/be639d19-adcb-49c9-954d-c314fed4cca6

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd