Immunotech SAS, a Beckman Coulter CompanyMarch 14, 2024

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

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Record Details

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.

Company: Immunotech SAS, a Beckman Coulter Company
Inspection Date: March 14, 2024
Product Type: Device
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
Person: John A. Sciacchitano (investigator)

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ID · f4f69c36-e817-4606-82eb-e654748ec9a2