DFI Co., Ltd. – FDA Warning Letter, Jan 9, 2025

On May 6, 2025, the FDA issued a Warning Letter to DFI Co., Ltd. following an inspection from January 6-9, 2025, at their Gimhae, Gyeongsangnam, Korea facility. The inspection revealed that their CYBOW 11 Reagent Strips for Urinalysis are adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820) and Medical Device Reporting (MDR) requirements (21 CFR 803.17).

Key violations include: 1. **Complaint Handling (21 CFR 820.198(a)):** Failure to establish adequate procedures for receiving, reviewing, and evaluating complaints. Numerous complaints were not entered into the formal system, and the updated procedure is inadequate, lacking uniform processing, timely evaluation, and proper investigation of all potential device failures. 2. **Nonconforming Product (21 CFR 820.90):** Failure to establish and maintain adequate procedures to control nonconforming product. Examples include retesting failed pH values without proper documentation, segregation, or disposition, and allowing retesting at QC stages without evaluating nonconformance or investigating. 3. **Labeling Control (21 CFR 820.120):