# FDA 483 - Immunodiagnostic  Systems Sa - September 07, 2023

Source: https://www.globalkeysolutions.net/records/483/immunodiagnostic-systems-sa/887e2449-2349-4398-a5ea-56d8c6998145

> FDA 483 for Immunodiagnostic  Systems Sa on September 07, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Immunodiagnostic  Systems Sa
- Inspection Date: 2023-09-07
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Immunodiagnostic Systems Sa in Liege, Belgium, revealed significant deficiencies in their corrective and preventive action (CAPA) procedures. The firm's CAPA SOPs did not require effectiveness checks, leading to multiple CAPA reports where effectiveness was either not assessed or only a correction was listed. This indicates a critical breakdown in ensuring the long-term efficacy of corrective actions for product quality issues.

## Related Officers

- [Cso](https://www.globalkeysolutions.net/people/daniel-j-lahar/d4e329c0-b6a5-42ca-acde-b79413b245ea)

Company: https://www.globalkeysolutions.net/companies/immunodiagnostic-systems-sa/e1927040-b1cb-49f6-8463-64fa285f4016

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