Loading…
DFI Co., Ltd., a South Korean manufacturer of CYBOW 11 Reagent Strips for Urinalysis, was cited for failing to comply with FDA's Quality System Regulation (21 CFR Part 820) for medical devices. During an inspection conducted January 6-9, 2025, the FDA determined that the company's complaint handling procedures were inadequate, with evidence showing that not all complaints—including those involving possible device specification failures—were properly entered into the firm's complaint handling system for evaluation and investigation between 2022 and 2024. The adulteration violations indicated that the company's manufacturing methods, facilities, and controls did not meet current good manufacturing practice requirements.