FDA 483 - Precision Edge Surgical Products Company LLC. - July 11, 2025

An FDA inspection of Precision Edge Surgical Products Company LLC, a medical device manufacturer in Sault Sainte Marie, MI, was conducted from July 7 to July 11, 2025. The inspection identified a significant issue concerning the company's training program. Specifically, their Competence, Awareness, and Training procedure (QSP-007) was found to be insufficient in ensuring employees received necessary training for their roles. Records indicated that approximately 35 employees had one or more assigned trainings past their required completion dates. Furthermore, the established training monitoring process within the procedure was not effectively identifying or resolving these overdue training requirements. This observation points to a lack of adherence to quality system regulations, as outlined under the Federal Food, Drug, and Cosmetic Act, which mandates robust control over personnel qualifications to ensure product quality and patient safety. Precision Edge Surgical Products Company LLC is responsible for conducting internal self-audits to identify and correct all quality system violations and has committed to addressing the noted observation through corrective actions.