Maquet SASJanuary 16, 2025

FDA 483 - Maquet SAS - January 16, 2025

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Record Details

Maquet SAS, a medical device manufacturer in Orleans cedex 2, France, was inspected by the FDA from January 13-16, 2025. The inspection revealed deficiencies in the firm's procedures for controlling nonconforming products and for establishing adequate device history records. These issues indicate a lack of robust quality system controls.

Company: Maquet SAS
Inspection Date: January 16, 2025
Product Type: Device
Office: Office of Inspections and Investigations
Person: John A. Sciacchitano (investigator)

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ID · 6a029879-bc9b-4eb0-b0c0-9a76009a6314