Les Encres LLC

During an inspection of your firm Les Encres LLC, FEI 3014822674 located at 149 Kelsey Ln Ste 200 B in Lenoir City, Tennessee, on March 14, 2025, through April 1, 2025, an investigator from the United States Food and Drug Administration (FDA) determined that your firm is a specification developer of Les Encres absorbable polydioxanone (PDO) surgical suture devices (“Les Encres threads”). Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.

This inspection revealed that these devices are adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. These violations include, but are not limited to, the following:

1. 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, as required by 21 CFR 820.198. Specifically, you failed to document, review, and evaluate complaints as required by your procedure “Complaint Handling,” MD34, Rev A, dated 05/01/2023. For example, you received e-mails with alleged deficiencies potentially related to the identity, quality, durability, reliability, safety, effectiveness, or performance of your absorbable PDO surgical suture devices. These complaints were not logged, assigned a complaint number, assessed for complaint category type, investigated, reviewed for reportability, evaluated to determine if your device met all specifications and claims, nor evaluated to determine if corrective and preventive actions were needed as required by your procedure MD34.

2. Failure to adequately maintain procedures for implementing corrective and preventive action, and to document all activities required under the procedures, as required by 21 CFR 820.100(a) and (b). Specifically, you failed to implement your procedure “Corrective and Preventive Action,” MD30, Rev A, dated 05/01/2023, which requires your firm to document corrective and preventive actions (CAPA), and to verify or validate that CAPAs are effective. Your procedure MD30 Section 7.2 requires CAPAs to be documented on form “Corrective and Preventive Action Report,” MD30-RF1, and to be logged on the “Corrective and Preventive Action Report Log,” MD30-LB1. In your written response to FDA on 05/31/2023, responding to your previous inspection, you detailed your activities performed in response to your FDA Inspectional Observations that included opening CAPA 23-001, CAPA 23-002, CAPA 23-003, and CAPA 23-004. However, this inspection found that your CAPA Log MD30-LB1 has no entries, and you have no documented CAPA records.

3. Failure to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50. Specifically, you do not have a procedure that describes the process by which suppliers, contractors, or consultants are evaluated and how their approval status is documented. You did not document the results of any evaluation performed by you that qualifies your supplier of absorbable PDO surgical sutures.

4. Failure to adequately ensure that all personnel are trained to adequately perform their assigned responsibilities, and document training, as required by 21 CFR 820.25(b). Specifically,

a. Your procedure “Complaint Handling” MD34, Rev A. dated 05/01/2023 details the responsibilities of all employees on how complaints are to be handled. Your statements, together with this procedure and the “Clinical Specialist Job Description,” indicate your Clinical Specialist is responsible for complaint investigations. However, you have confirmed that the Clinical Specialist has not been trained on your current complaint handling procedure. At least five complaints concerning absorbable PDO surgical sutures, received between (b)(4) and (b)(4), were not documented, investigated, or handled as complaint records as required by your procedure MD34.

b. Your procedure “Complaint Handling” MD34, Rev A. dated 05/01/2023, Section 5.5 identifies that sales and marketing personnel are responsible for assisting in performing and documenting complaint investigation activities. In addition, you stated that sales representatives are responsible for intake of complaint data and fill in as needed for complaint investigation activities. You indicated your salespeople have been trained on your procedure MD34; however, there is no documented evidence that shows this training was completed.

Failure to adequately develop, maintain, and implement written MDR procedures as required by 21 CFR 803.17. For example, your firm presented the document titled “Medical Device Reporting”, MD33, Rev A, DCO: 23-002, dated 05/01/2023, as your MDR procedure. Upon review, we concluded that your MDR procedure does not establish internal systems that provide for a standardized review process or procedure to determine when an event meets the criteria for reporting under this part, as required by 21 CFR 803.17(a)(2). For example, although Sections 6.2-6.3 of your procedure MD33 include a requirement to conduct investigations of MDR reportable events, your procedure lacks the instructions on how to perform the investigation and evaluate the cause of such events.

Additionally, your firm is recommended to establish an active Electronic Submissions Gateway (ESG) production account for the electronic submission of MDR reports. FDA verified that, as of June 9, 2025, your firm does not have such an account. Information about the ESG can be found at: How to Enroll in eMDR Program | FDA.

FDA has reviewed information during the inspection and on your website and determined that your Les Encres threads are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption under section 520(g) of the Act, 21 U.S.C. § 360j(g) for the device as described and marketed. The device is also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), because your firm introduced or delivered for introduction into interstate commerce for commercial distribution these devices with major changes or modifications to the intended use without submitting a new premarket notification to FDA as required by section 510(k) of the Act, 21 U.S.C. § 360(k) and 21 CFR 807.81(a)(3)(ii).

Specifically, your Les Encres threads were cleared under K190264 with the following indications: “barbed suture comprised of dyed polydioxanone (PDO) is indicated for use in soft tissue approximation where use of absorbable suture is appropriate.” However, your firm’s promotion of the devices (as noted in the examples below) provides evidence that the devices are intended for specific cosmetic uses, which would constitute a major change or modification to their intended use, for which your firm lacks clearance or approval.

One example can be found on your Les Encres website (https://lesencres.com/company/faqpage/ reviewed on 07/23/2025):

“Using Les Encres Threads, we can lift, tighten and add volume where needed, all in the time it takes you to eat lunch.”

Another example is your Les Encres Product Listing titled “les encres Threads – Les Encres Product Request” (collected during FDA inspection 03/14/2025 – 04/01/2025):

“Ideal for Light cheek lift, Jawline lift, Neck lift, Brow lift and Lower Face treatments.”

We discussed these issues with you in 2024 regarding promotion of your devices with statements beyond the scope of the cleared 510(k). FDA is currently unaware of any evidence you have submitted that could support the above intended uses of your devices. The above intended uses of tightening and adding volume raise safety and effectiveness concerns that are different from those normally associated with the cleared use of the devices. Use of the devices for cosmetic purposes presents additional risks such as migration, extrusion, asymmetry, visible scarring, and poor cosmetic outcomes that generally require clinical data to demonstrate safety in superficial dermal/subdermal use and to confirm the durability and predictability of cosmetic results before such statements can be made. Your barbed sutures have not been cleared for such indications and you have not submitted data demonstrating safety and effectiveness for such use. We strongly recommended that you conduct the performance testing appropriate for barbed sutures and submit a new 510(k) notification, including identifying a suitable predicate device to the Agency. This submission is necessary to obtain clearance for marketing of your Les Encres threads for the above intended uses, which carry clinical implications not normally associated with the cleared use of the device. Furthermore, we emphasize that for any cosmetic use related to sutures, the Agency has required comprehensive performance testing, including clinical evidence, to establish substantial equivalence to a legally marketed predicate device. This information must be submitted as part of a new 510(k) submission.

For a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. § 360(k), is deemed satisfied when a PMA is pending before the agency. The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.

Our office requests that Les Encres cease any activities that result in the misbranding or adulteration of the Les Encres threads, such as the commercial distribution of the devices for the uses discussed above.

Your firm should take prompt action to address any violations identified in this letter. Failure to adequately address this matter may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties. Other federal agencies may take your compliance with the FD&C Act and its implementing regulations into account when considering the award of federal contracts. Additionally, should FDA determine that you have Quality System regulation violations that are reasonably related to premarket approval applications for Class III devices, such devices will not be approved until the violations have been addressed. Should FDA determine that your devices or facilities do not meet the requirements of the Act, requests for Certificates to Foreign Governments (CFG) may not be granted.

Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to address the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (which must address systemic problems) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address any violations included in this Warning Letter. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration as part of your response.

Your firm’s response should be sent to Melissa Michurski, Assistant Director, via email to cdrhenforcement@fda.hhs.gov. Please include in the subject line, CMS Case 709263 when replying. If you have any questions about the contents of this letter, please contact Demetria Lueneburg, Compliance Officer, at Demetria.Lueneburg@fda.hhs.gov.

Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of any violations and take prompt actions to address any violations and bring the products into compliance.