# FDA 483 - Barco N.V. - September 14, 2023

Source: https://www.globalkeysolutions.net/records/483/barco-nv/b1afed70-7f8b-4d61-8301-fcd8971084d9

> FDA 483 for Barco N.V. on September 14, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Barco N.V.
- Inspection Date: 2023-09-14
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Barco N.V., a medical device manufacturer, was cited with six observations during an FDA inspection, highlighting significant deficiencies in their quality system. The firm failed to maintain adequate procedures for Medical Device Reporting (MDRs), corrective and preventive actions (CAPA), and complaint handling. Additionally, issues were noted with undocumented personnel training and insufficient controls over critical suppliers, indicating a systemic breakdown in regulatory compliance.

## Related Officers

- [Esteban Beltran](https://www.globalkeysolutions.net/people/esteban-beltran/9a9bf6b2-ecdf-494c-82f4-5ef5932d629a)

Company: https://www.globalkeysolutions.net/companies/barco-nv/36a8738a-7a3f-48a0-b2a0-d0c6ce5c0d65

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