# FDA 483 - Immunotech SAS, a Beckman Coulter Company - March 14, 2024

Source: https://www.keypedia.com/records/483/immunotech-sas-a-beckman-coulter-company/f4f69c36-e817-4606-82eb-e654748ec9a2

> FDA 483 for Immunotech SAS, a Beckman Coulter Company on March 14, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Immunotech SAS, a Beckman Coulter Company
- Inspection Date: 2024-03-14
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Immunotech SAS, a Beckman Coulter Company, in Marseille, France, revealed deficiencies in equipment maintenance and documentation practices. The firm failed to adequately establish and document maintenance schedules and activities for DXI 9000 machines. Additionally, maintenance record forms were not under proper document control, indicating issues with the firm's quality system.

## Related Officers

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

Company: https://www.keypedia.com/companies/immunotech-sas-a-beckman-coulter-company/5fe478f1-db9f-40e1-b016-7e1de0f5bbd9

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