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# QS Issues at DFI Company
- URL: https://www.fdaweb.com/qs-issues-at-dfi-company/
- Published: 2025-06-04T12:00:00.000Z
- Updated: 2026-09-14T15:13:32.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5159301

A 1/6-1/9 FDA inspection at DFI Co., Ltd. in Gimhae, Gyeongsangnam, Korea, found Quality System Regulation violations in the firm’s manufacturing of Cybow reagent strips for urinalysis. A 5/6 Warning Letter says the specific violations were:

- failure to establish and maintain adequate procedures for receiving, reviewing, and evaluating complaints by a formally designated unit;
- failure to establish and maintain adequate procedures to control product that does not conform to specified requirements;
- failure to establish and maintain adequate procedures to control labeling activities;
- failure to establish and maintain adequate procedures to ensure that device history records for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the device master record; and
- failure to identify by suitable means the acceptance status of product, to indicate the conformance or nonconformance product with acceptance criteria.

The inspection also determined the company failed to develop, maintain, and implement written Medical Device Reporting procedures.

DFI was told to respond with a list of specific actions it has taken to address the violations and prevent their recurrence, with documentation of each step and a schedule for completing the corrections.