FDA 483 - Precision Edge Surgical Products Co. LLC. - November 20, 2025

Precision Edge Surgical Products Co. LLC in Boyne City, MI, was issued a Form 483 with two observations following an FDA inspection. The firm's process validation for its medical device (b)(4) System was found inadequate, with operations occurring outside validated parameters and insufficient process characterization. Additionally, the company failed to establish and implement adequate training procedures for personnel involved in nonconformance identification and quality inspections.