FDA 483 - C4 Imaging LLC - January 16, 2024

During an inspection conducted from January 15-16, 2024, at C4 Imaging LLC, a medical device manufacturer in Bellaire, TX, the U.S. Food and Drug Administration (FDA) issued a Form FDA 483, citing three observations related to the firm's quality system. The inspection revealed that C4 Imaging LLC failed to conduct and document a management review of its quality system for 2023, despite its own standard operating procedures requiring an annual review. Additionally, the firm did not perform or document quality audits at defined intervals, which is crucial for ensuring compliance with established quality system procedures. A further observation noted the absence of documented evaluations for potential suppliers, specifically citing a PEEK material provider, contrary to the firm's supplier qualification procedures that mandate documented evaluations and re-evaluations. These observations highlight deficiencies in C4 Imaging LLC's adherence to its internal quality system procedures, which are essential for maintaining compliance with medical device regulations. The firm is expected to address these issues by implementing appropriate corrective actions to ensure the suitability and effectiveness of its quality system, including thorough management reviews, timely internal audits, and proper supplier qualification documentation.