483
Les Encres LLCLes Encres LLC – FDA 483, Apr 1, 2025
Record Details
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.
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