# FDA 483 - Cavex Holland B.V. - March 05, 2020

Source: https://www.keypedia.com/records/483/cavex-holland-bv/29fa37e7-ed8a-437e-aa6a-936ad0b66cd1

> FDA 483 for Cavex Holland B.V. on March 05, 2020. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Cavex Holland B.V.
- Inspection Date: 2020-03-05
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Cavex Holland B.V., a manufacturer in Haarlem, Netherlands, identified three significant quality system deficiencies. The firm's MDR procedure lacked a standardized review process for adverse event reporting, and two complaints meeting reporting criteria were not submitted. Additionally, management review procedures were not adequately established, failing to report supplier performance, and procedures for ensuring purchased products and services conform to requirements were deficient, as evidenced by a lack of documentation for calibration service provider evaluations.

## Related Officers

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

Company: https://www.keypedia.com/companies/cavex-holland-bv/e858ef2e-3720-4add-80b3-7941d4bf5b70

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