FDA 483 - Les Encres LLC - April 01, 2025

Les Encres LLC, a private labeler in Lenoir City, TN, received a Form 483 with six observations during an FDA inspection. The firm demonstrated significant deficiencies in its quality system, including inadequate procedures for complaint handling, medical device reporting, corrective and preventive actions, supplier control, training, and document control. Many of these issues were repeat observations from a previous inspection, indicating a systemic lack of compliance.