Les Encres LLC

Warning LetterOpen

Stacey R. Reynolds CEO Les Encres LLC 149 Kelsey Ln Ste 200 B Lenoir City , TN 37772 United States sreynolds@lesencres.comFEI 3014822674Issued Jul 30, 2025Center for Devices and Radiological Health

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Letter Details

Firm: Les Encres LLC
Location: Stacey R. Reynolds CEO Les Encres LLC 149 Kelsey Ln Ste 200 B Lenoir City , TN 37772 United States sreynolds@lesencres.com
FEI Number: 3014822674
Country: United States
Issue Date: July 30, 2025
Issuing Office: Center for Devices and Radiological Health
Product Type: Medical Devices
Status: Open

Summary

Les Encres LLC, a manufacturer of absorbable polydioxanone (PDO) surgical suture devices, failed to comply with Quality System Regulation (QSR) requirements under 21 CFR Part 820, rendering their products adulterated. During an FDA inspection in March-April 2025, investigators identified critical violations including failure to maintain adequate complaint files and procedures for receiving, reviewing, and evaluating complaints as required by 21 CFR 820.198, with specific instances where the company received emails regarding potential deficiencies in device identity, quality, durability, reliability, safety, and performance but failed to properly document and investigate them. The company's complaint handling procedure (MD34, Rev A) was not being followed as required.