FDA 483 - Maquet SAS - January 16, 2025

This FDA Form 483 document outlines observations made during an inspection of Maquet SAS, a medical device manufacturer located in Orleans cedex 2, France. The inspection was conducted by the U.S. Food and Drug Administration from January 13 to January 16, 2025. The inspection identified two primary issues related to the company's quality system. Firstly, procedures for controlling nonconforming product were deemed inadequate. Specifically, the firm's nonconformance procedures lacked sufficient detail regarding documentation requirements for nonconformance records and the criteria for initiating necessary investigations. Secondly, procedures for device history records (DHR) were not adequately established. The DHR procedures did not clearly define the acceptance records to be included, nor did they sufficiently account for the inclusion or reference of in-process nonconformance records within the DHR documentation. These observations, issued under the Federal Food, Drug, and Cosmetic Act, indicate areas where the firm's quality system requirements are not fully met. Maquet SAS is expected to conduct internal self-audits to address these identified conditions and implement appropriate corrective actions to ensure compliance with regulatory standards. The document clarifies that these are inspectional observations, not a final agency determination of compliance, but underscore the need for the company to refine its quality control and documentation processes.