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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.