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# Multiple Les Encres Violations
- URL: https://www.fdaweb.com/multiple-les-encres-violations/
- Published: 2025-08-19T12:00:00.000Z
- Updated: 2026-09-14T15:19:21.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5159707

A 3/14-4/1 FDA inspection at Les Encres LLC in Lenoir City, TN, found multiple violations in the firm’s work as a specification developer of Les Encres absorbable polydioxanone surgical suture devices. A just-released 7/30 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/les-encres-llc-709263-07302025?ref=fdaweb.com) says Quality System regulation violations were:

- failure to maintain complaint files and to adequately maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, to review and evaluate all complaints to determine whether an investigation is necessary, and to review, evaluate, and investigate any complaint involving the possible failure of the device, labeling, or packaging;
- failure to adequately maintain procedures for implementing corrective and preventive action, and to document all activities required under the procedures;
- failure to establish and maintain procedures to ensure that all purchased or otherwise received products and services conform to specified requirements; and
- failure to adequately ensure that all personnel are trained to adequately perform their assigned responsibilities.

The letter says the firm’s Medical Device Reporting (MDR) procedure does not establish internal systems providing for a standardized review process or procedure to determine when an event meets the criteria for reporting under the regulations. FDA recommends that Les Encres establish an Electronic Submissions Gateway account for the electronic submission of MDR reports.

FDA also says that while the firm’s threads were cleared through a 510(k), there is evidence in the promotional material for the devices that they are intended for specific cosmetic areas, which is considered a major change or modification to their intended use, for which the company lacks approval. The letter says the devices are adulterated because Les Encres does not have an approved PMA or IDE in effect, and misbranded because they were introduced into interstate commerce with major changes or modifications to the intended use without submitting a new premarket notification to FDA.

The agency asks Les Encres to cease any activities that result in the misbranding or adulteration of the threads, such as the commercial distribution of the devices for the uses cited in the letter.

The company was told to correct the violations promptly and to respond with a list of specific steps it has taken to address the violations and prevent their recurrence, with documentation of each step, and a schedule for completing the corrections.