FDA WARNING_LETTER - Les Encres LLC - April 01, 2025

Les Encres LLC, located in Lenoir City, Tennessee, was inspected by the FDA from March 14 to April 1, 2025. The inspection revealed significant violations of the Quality System Regulation under Title 21 CFR Part 820, indicating that the company’s absorbable polydioxanone (PDO) surgical suture devices are adulterated. Key violations include inadequate complaint handling procedures, failure to implement corrective and preventive actions, lack of supplier evaluation processes, insufficient personnel training, and inadequate Medical Device Reporting (MDR) procedures.

The FDA noted that Les Encres failed to maintain proper documentation for complaints and corrective actions, did not establish procedures for supplier evaluations, and lacked evidence of employee training on complaint handling. Additionally, the company’s MDR procedures were found lacking in standardized processes for determining reportable events, and the firm does not have an active Electronic Submissions Gateway account for MDR reports.

Furthermore, the Les Encres threads are considered adulterated and misbranded under sections 501(f)(1)(B) and 502(o) of the Federal Food, Drug, and Cosmetic Act. The company lacks premarket approval or an investigational device exemption for the marketed devices, and changes to the intended use without proper notification to the FDA constitute a violation.

The FDA requires Les Encres to address these violations by implementing corrective actions, establishing proper documentation and training procedures, and ensuring compliance with regulatory requirements. The company must also rectify the lack of premarket approval for the modified use of its devices.